Diabetes Mellitus, Type 2Phase 3NCT00736099

Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM

A Phase 3 study testing linagliptine 5 mg and linagliptine 5 mg and pioglitazone 30 mg in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 232 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment. The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy… Read more about this study

Who is it for?: Ages 18 to 82 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: linagliptine 5 mg and linagliptine 5 mg and pioglitazone 30 mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,122 participants
Where: 232 sitesin 32 countries
Study dates: Aug 2008to Dec 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 82 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed and dated written informed consent in accordance with the GCP and local legislation.
Patients completing the entire treatment period as a double blind trial whether or not they have been treated with rescue medication.

Who cannot join

Patients who meet one or more of the withdrawal criteria of the treatment period of the previous trial.
Pre-menopausal women (last menstruation =< 1 year prior to signing informed consent) who:
are nursing or pregnant,
or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of birth control) and vasectomised partners. No exception will be made.
Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation.
Drug abuse which, in the opinion of the investigator, would interfere with trial participation.
Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.

Trial locations and contacts

232 sites in 32 countries.

Country

City, postcode or hospital

232 sites in 32 countries

India14 sites

1218.40.91010 Boehringer Ingelheim Investigational Site
Andhra Pradesh
1218.40.91002 Boehringer Ingelheim Investigational Site
Bangalore
1218.40.91005 Boehringer Ingelheim Investigational Site
Bangalore
1218.40.91012 Boehringer Ingelheim Investigational Site
Chennai
1218.40.91014 Boehringer Ingelheim Investigational Site
Chennai
1218.40.91009 Boehringer Ingelheim Investigational Site
Hyderabad, Andra Pradesh
1218.40.91006 Boehringer Ingelheim Investigational Site
Jaipur
1218.40.91001 Boehringer Ingelheim Investigational Site
Kerala
1218.40.91011 Boehringer Ingelheim Investigational Site
Maharashtra
1218.40.91008 Boehringer Ingelheim Investigational Site
Mangalore
1218.40.91007 Boehringer Ingelheim Investigational Site
Manipal
1218.40.91004 Boehringer Ingelheim Investigational Site
Mumbai
1218.40.91003 Boehringer Ingelheim Investigational Site
Nashik
1218.40.91013 Boehringer Ingelheim Investigational Site
Uttar Pradesh

Other trials in India

United States13 sites

1218.40.10003 Boehringer Ingelheim Investigational Site
Chula Vista, California
1218.40.10005 Boehringer Ingelheim Investigational Site
Dallas, Texas
1218.40.10016 Boehringer Ingelheim Investigational Site
Eugene, Oregon
1218.40.10009 Boehringer Ingelheim Investigational Site
Federal Way, Washington
1218.40.10002 Boehringer Ingelheim Investigational Site
Greer, South Carolina
1218.40.10010 Boehringer Ingelheim Investigational Site
Hollywood, Florida
1218.40.10018 Boehringer Ingelheim Investigational Site
Houston, Texas
1218.40.10011 Boehringer Ingelheim Investigational Site
Miami, Florida
1218.40.10021 Boehringer Ingelheim Investigational Site
Northglenn, Colorado
1218.40.10007 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1218.40.10004 Boehringer Ingelheim Investigational Site
Simpsonville, South Carolina
1218.40.10014 Boehringer Ingelheim Investigational Site
Spring Valley, California
1218.40.10001 Boehringer Ingelheim Investigational Site
Walnut Creek, California

Other trials in United States

Canada13 sites

1218.40.01005 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1218.40.01010 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1218.40.01006 Boehringer Ingelheim Investigational Site
Etobicoke, Ontario
1218.40.01009 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1218.40.01002 Boehringer Ingelheim Investigational Site
London, Ontario
1218.40.01004 Boehringer Ingelheim Investigational Site
Montague, Prince Edward Island
1218.40.01012 Boehringer Ingelheim Investigational Site
Oakville, Ontario
1218.40.01008 Boehringer Ingelheim Investigational Site
Sarnia, Ontario
1218.40.01007 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
1218.40.20005 Boehringer Ingelheim Investigational Site
Strathroy, Ontario
1218.40.01001 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1218.40.01003 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1218.40.01011 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia

Other trials in Canada

China13 sites

1218.40.86001 Boehringer Ingelheim Investigational Site
Beijing
1218.40.86002 Boehringer Ingelheim Investigational Site
Beijing
1218.40.86004 Boehringer Ingelheim Investigational Site
Beijing
1218.40.86013 Boehringer Ingelheim Investigational Site
Chengdu
1218.40.86009 Boehringer Ingelheim Investigational Site
Dalian
1218.40.86011 Boehringer Ingelheim Investigational Site
Guangzhou
1218.40.86014 Boehringer Ingelheim Investigational Site
Haerbin
1218.40.86008 Boehringer Ingelheim Investigational Site
Qingdao
1218.40.86015 Boehringer Ingelheim Investigational Site
Shanghai
1218.40.86010 Boehringer Ingelheim Investigational Site
Shenyang
1218.40.86007 Boehringer Ingelheim Investigational Site
Wuhan
1218.40.86012 Boehringer Ingelheim Investigational Site
Wuhan
1218.40.86006 Boehringer Ingelheim Investigational Site
Xi'an

Other trials in China

Spain12 sites

1218.40.34002 Boehringer Ingelheim Investigational Site
Badalona
1218.40.34011 Boehringer Ingelheim Investigational Site
Badia Del Vallés
1218.40.34012 Boehringer Ingelheim Investigational Site
Borges Del Camp
1218.40.34013 Boehringer Ingelheim Investigational Site
Centelles
1218.40.34007 Boehringer Ingelheim Investigational Site
Granada
1218.40.34008 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat (Barcelona)
1218.40.34009 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat (Barcelona)
1218.40.34004 Boehringer Ingelheim Investigational Site
Madrid
1218.40.34006 Boehringer Ingelheim Investigational Site
Madrid
1218.40.34010 Boehringer Ingelheim Investigational Site
Sant Adrià Del Besós (Barcelona)
1218.40.34005 Boehringer Ingelheim Investigational Site
Seville
1218.40.34014 Boehringer Ingelheim Investigational Site
Vic (Barcelona)

Other trials in Spain

Ukraine12 sites

1218.40.38011 Boehringer Ingelheim Investigational Site
Dnipro
1218.40.38002 Boehringer Ingelheim Investigational Site
Kharkiv
1218.40.38004 Boehringer Ingelheim Investigational Site
Kharkiv
1218.40.38010 Boehringer Ingelheim Investigational Site
Kharkiv
1218.40.38001 Boehringer Ingelheim Investigational Site
Kiev
1218.40.38005 Boehringer Ingelheim Investigational Site
Kiev
1218.40.38008 Boehringer Ingelheim Investigational Site
Kiev
1218.40.38009 Boehringer Ingelheim Investigational Site
Kiev
1218.40.38012 Boehringer Ingelheim Investigational Site
Kiev
1218.40.38003 Boehringer Ingelheim Investigational Site
Lviv
1218.40.38006 Boehringer Ingelheim Investigational Site
Vinnitsa
1218.40.38007 Boehringer Ingelheim Investigational Site
Zaporizhzhya

Other trials in Ukraine

Russia11 sites

1218.40.70014 Boehringer Ingelheim Investigational Site
Arkhangelsk
1218.40.70001 Boehringer Ingelheim Investigational Site
Moscow
1218.40.70002 Boehringer Ingelheim Investigational Site
Moscow
1218.40.70003 Boehringer Ingelheim Investigational Site
Moscow
1218.40.70012 Boehringer Ingelheim Investigational Site
Moscow
1218.40.70005 Boehringer Ingelheim Investigational Site
Novosibirsk
1218.40.70006 Boehringer Ingelheim Investigational Site
Perm
1218.40.70013 Boehringer Ingelheim Investigational Site
Rostov-on-Don
1218.40.70015 Boehringer Ingelheim Investigational Site
Saint Petersburg
1218.40.70016 Boehringer Ingelheim Investigational Site
Samara
1218.40.70004 Boehringer Ingelheim Investigational Site
Tomsk

Other trials in Russia

South Korea11 sites

1218.40.82002 Boehringer Ingelheim Investigational Site
Busan
1218.40.82011 Boehringer Ingelheim Investigational Site
Daegu
1218.40.82008 Boehringer Ingelheim Investigational Site
Incheon
1218.40.82010 Boehringer Ingelheim Investigational Site
Jeonju
1218.40.82004 Boehringer Ingelheim Investigational Site
Pusan
1218.40.82001 Boehringer Ingelheim Investigational Site
Seoul
1218.40.82005 Boehringer Ingelheim Investigational Site
Seoul
1218.40.82006 Boehringer Ingelheim Investigational Site
Seoul
1218.40.82007 Boehringer Ingelheim Investigational Site
Seoul
1218.40.82009 Boehringer Ingelheim Investigational Site
Seoul
1218.40.82003 Boehringer Ingelheim Investigational Site
Suwon

Other trials in South Korea

Mexico10 sites

1218.40.52007 Boehringer Ingelheim Investigational Site
Aguascalientes, Ags.
1218.40.52010 Boehringer Ingelheim Investigational Site
Col.Americana, Guadalajara, Jalisco
1218.40.52008 Boehringer Ingelheim Investigational Site
Colonia Tlalpan, Mexico
1218.40.52006 Boehringer Ingelheim Investigational Site
Faccionamiento Lomas de Campestre,AGUASCAL
1218.40.52009 Boehringer Ingelheim Investigational Site
León
1218.40.52002 Boehringer Ingelheim Investigational Site
México
1218.40.52004 Boehringer Ingelheim Investigational Site
México
1218.40.52005 Boehringer Ingelheim Investigational Site
México
1218.40.52003 Boehringer Ingelheim Investigational Site
Monterrey
1218.40.52001 Boehringer Ingelheim Investigational Site
Monterrey N.L.

Other trials in Mexico

United Kingdom9 sites

1218.40.44005 Boehringer Ingelheim Investigational Site
Ashford
1218.40.44004 Boehringer Ingelheim Investigational Site
Baillieston, Glasgow
1218.40.44001 Boehringer Ingelheim Investigational Site
Bath
1218.40.44003 Boehringer Ingelheim Investigational Site
Burbage
1218.40.44010 Boehringer Ingelheim Investigational Site
Bury Saint Edmonds
1218.40.44009 Boehringer Ingelheim Investigational Site
Cardiff
1218.40.44002 Boehringer Ingelheim Investigational Site
Penarth
1218.40.44006 Boehringer Ingelheim Investigational Site
Reading
1218.40.44007 Boehringer Ingelheim Investigational Site
Waterloo, Liverpool

Other trials in United Kingdom

Germany8 sites

1218.40.49028 Boehringer Ingelheim Investigational Site
Bad Mergentheim
1218.40.49022 Boehringer Ingelheim Investigational Site
Berlin
1218.40.49024 Boehringer Ingelheim Investigational Site
Bosenheim
1218.40.49020 Boehringer Ingelheim Investigational Site
Dresden
1218.40.49101 Boehringer Ingelheim Investigational Site
Mainz
1218.40.49003 Boehringer Ingelheim Investigational Site
Neuwied
1218.40.49007 Boehringer Ingelheim Investigational Site
Nuremberg
1218.40.49014 Boehringer Ingelheim Investigational Site
Saarbrücken

Other trials in Germany

Taiwan8 sites

1218.40.88605 Boehringer Ingelheim Investigational Site
Changhua
1218.40.88604 Boehringer Ingelheim Investigational Site
Taichung
1218.40.88606 Boehringer Ingelheim Investigational Site
Tainan
1218.40.88601 Boehringer Ingelheim Investigational Site
Taipei
1218.40.88602 Boehringer Ingelheim Investigational Site
Taipei
1218.40.88603 Boehringer Ingelheim Investigational Site
Taipei
1218.40.88607 Boehringer Ingelheim Investigational Site
Taipei
1218.40.88608 Boehringer Ingelheim Investigational Site
Taoyuan

Other trials in Taiwan

Belgium7 sites

1218.40.32005 Boehringer Ingelheim Investigational Site
Bruges
1218.40.32007 Boehringer Ingelheim Investigational Site
Brussels
1218.40.32006 Boehringer Ingelheim Investigational Site
Edegem
1218.40.32004 Boehringer Ingelheim Investigational Site
Genk
1218.40.32003 Boehringer Ingelheim Investigational Site
Ghent
1218.40.32002 Boehringer Ingelheim Investigational Site
Huy
1218.40.32001 Boehringer Ingelheim Investigational Site
Liège

Other trials in Belgium

Greece7 sites

1218.40.30004 Boehringer Ingelheim Investigational Site
Athens
1218.40.30007 Boehringer Ingelheim Investigational Site
Athens
1218.40.30013 Boehringer Ingelheim Investigational Site
Athens
1218.40.30003 Boehringer Ingelheim Investigational Site
Nikaia
1218.40.30011 Boehringer Ingelheim Investigational Site
Piraeus
1218.40.30006 Boehringer Ingelheim Investigational Site
Thessaloniki
1218.40.30016 Boehringer Ingelheim Investigational Site
Thessaloniki

Other trials in Greece

Israel7 sites

1218.40.97274 Boehringer Ingelheim Investigational Site
Afula
1218.40.97273 Boehringer Ingelheim Investigational Site
Haifa
1218.40.97275 Boehringer Ingelheim Investigational Site
Holon
1218.40.97271 Boehringer Ingelheim Investigational Site
Jerusalem
1218.40.97272 Boehringer Ingelheim Investigational Site
Nahariya
1218.40.97276 Boehringer Ingelheim Investigational Site
Safed
1218.40.97278 Boehringer Ingelheim Investigational Site
Tel Aviv

Other trials in Israel

Romania7 sites

1218.40.40504 Boehringer Ingelheim Investigational Site
Alba Iulia
1218.40.40604 Boehringer Ingelheim Investigational Site
Brasov
1218.40.40501 Boehringer Ingelheim Investigational Site
Bucharest
1218.40.40502 Boehringer Ingelheim Investigational Site
Bucharest
1218.40.40603 Boehringer Ingelheim Investigational Site
Galati
1218.40.40503 Boehringer Ingelheim Investigational Site
Sibiu
1218.40.40505 Boehringer Ingelheim Investigational Site
Târgu Mureş

Other trials in Romania

Czechia6 sites

1218.40.42006 Boehringer Ingelheim Investigational Site
Břeclav
1218.40.42004 Boehringer Ingelheim Investigational Site
Brno
1218.40.42007 Boehringer Ingelheim Investigational Site
Brno
1218.40.42009 Boehringer Ingelheim Investigational Site
Brno
1218.40.42008 Boehringer Ingelheim Investigational Site
Hodonín
1218.40.42003 Boehringer Ingelheim Investigational Site
Olomouc

Other trials in Czechia

Hungary6 sites

1218.40.36003 Boehringer Ingelheim Investigational Site
Budapest
1218.40.36004 Boehringer Ingelheim Investigational Site
Budapest
1218.40.36006 Boehringer Ingelheim Investigational Site
Budapest
1218.40.36008 Boehringer Ingelheim Investigational Site
Debrecen
1218.40.36005 Boehringer Ingelheim Investigational Site
Győr
1218.40.36002 Boehringer Ingelheim Investigational Site
Szombathely

Other trials in Hungary

Malaysia6 sites

1218.40.60007 Boehringer Ingelheim Investigational Site
George Town
1218.40.60003 Boehringer Ingelheim Investigational Site
Kelantan
1218.40.60001 Boehringer Ingelheim Investigational Site
Kuala Lumpur
1218.40.60002 Boehringer Ingelheim Investigational Site
Kuala Lumpur
1218.40.60004 Boehringer Ingelheim Investigational Site
Perak
1218.40.60005 Boehringer Ingelheim Investigational Site
Perak

Other trials in Malaysia

Slovakia6 sites

1218.40.42103 Boehringer Ingelheim Investigational Site
Banská Bystrica
1218.40.42102 Boehringer Ingelheim Investigational Site
Bratislava
1218.40.42104 Boehringer Ingelheim Investigational Site
Bratislava
1218.40.42105 Boehringer Ingelheim Investigational Site
Bratislava
1218.40.42101 Boehringer Ingelheim Investigational Site
Nové Mesto
1218.40.42106 Boehringer Ingelheim Investigational Site
Šamorín

Other trials in Slovakia

Finland5 sites

1218.40.35806 Boehringer Ingelheim Investigational Site
Helsinki
1218.40.35801 Boehringer Ingelheim Investigational Site
Kuopio
1218.40.35803 Boehringer Ingelheim Investigational Site
Oulu
1218.40.35805 Boehringer Ingelheim Investigational Site
Seinäjoki
1218.40.35802 Boehringer Ingelheim Investigational Site
Turku

Other trials in Finland

Japan5 sites

1218.40.81001 Boehringer Ingelheim Investigational Site
Amagasaki, Hyogo
1218.40.81005 Boehringer Ingelheim Investigational Site
Koganei, Tokyo
1218.40.81002 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1218.40.81004 Boehringer Ingelheim Investigational Site
Shinjyuku-ku,Tokyo
1218.40.81003 Boehringer Ingelheim Investigational Site
Suita, Osaka,

Other trials in Japan

Netherlands5 sites

1218.40.31006 Boehringer Ingelheim Investigational Site
Deurne
1218.40.31001 Boehringer Ingelheim Investigational Site
Ewijk
1218.40.31010 Boehringer Ingelheim Investigational Site
Losser
1218.40.31008 Boehringer Ingelheim Investigational Site
Roelofarendsveen
1218.40.31002 Boehringer Ingelheim Investigational Site
Wildervank

Other trials in Netherlands

New Zealand5 sites

1218.40.64004 Boehringer Ingelheim Investigational Site
Christchurch
1218.40.64003 Boehringer Ingelheim Investigational Site
Dunedin
1218.40.64002 Boehringer Ingelheim Investigational Site
Otahuhu
1218.40.64001 Boehringer Ingelheim Investigational Site
Tauranga
1218.40.64005 Boehringer Ingelheim Investigational Site
Wellington

Other trials in New Zealand

Philippines5 sites

1218.40.63003 Boehringer Ingelheim Investigational Site
Greenhills, San Juan
1218.40.63005 Boehringer Ingelheim Investigational Site
Manila
1218.40.63002 Boehringer Ingelheim Investigational Site
Marikina City
1218.40.63001 Boehringer Ingelheim Investigational Site
Pasig
1218.40.63004 Boehringer Ingelheim Investigational Site
Quezon City

Other trials in Philippines

Argentina4 sites

1218.40.54002 Boehringer Ingelheim Investigational Site
Capital Federal
1218.40.54010 Boehringer Ingelheim Investigational Site
Capital Federal
1218.40.54011 Boehringer Ingelheim Investigational Site
Mendoza
1218.40.54015 Boehringer Ingelheim Investigational Site
Parque Velez Sarfield

Other trials in Argentina

Italy4 sites

1218.40.39008 Boehringer Ingelheim Investigational Site
Genova
1218.40.39002 Boehringer Ingelheim Investigational Site
Milan
1218.40.39001 Boehringer Ingelheim Investigational Site
Pisa
1218.40.39006 Boehringer Ingelheim Investigational Site
Roma

Other trials in Italy

Sweden4 sites

1218.40.46013 Boehringer Ingelheim Investigational Site
Härnösand
1218.40.46001 Boehringer Ingelheim Investigational Site
Malmö
1218.40.46012 Boehringer Ingelheim Investigational Site
Uddevalla
1218.40.46004 Boehringer Ingelheim Investigational Site
Uppsala

Other trials in Sweden

Poland3 sites

1218.40.48603 Boehringer Ingelheim Investigational Site
Lublin
1218.40.48601 Boehringer Ingelheim Investigational Site
Warsaw
1218.40.48604 Boehringer Ingelheim Investigational Site
Zabrze

Other trials in Poland

Austria2 sites

1218.40.43001 Boehringer Ingelheim Investigational Site
Graz
1218.40.43005 Boehringer Ingelheim Investigational Site
Vienna

Other trials in Austria

Croatia2 sites

1218.40.38605 Boehringer Ingelheim Investigational Site
Krapinske Toplice
1218.40.38604 Boehringer Ingelheim Investigational Site
Slavonski Brod

Other trials in Croatia

Thailand2 sites

1218.40.66001 Boehringer Ingelheim Investigational Site
Bangkok
1218.40.66002 Boehringer Ingelheim Investigational Site
Khon Kaen

Other trials in Thailand

About this study

Official title: A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 1356 (5 mg) as Monotherapy or in Combination With Other Antidiabetic Medications in Type 2 Diabetic Patients.

The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment.

The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin in combination with a sulphonylurea (patients in 1218.18 study)

Conditions: Diabetes Mellitus, Type 2
Being tested: linagliptine 5 mg, linagliptine 5 mg and pioglitazone 30 mg
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

linagliptine 5 mgDrug
safety and efficacy of linagliptine 5 mg open label
linagliptine 5 mg and pioglitazone 30 mgDrug
efficacy and safety of the combination linagliptine and pioglitazone

Study groups in NCT00736099
Study group	Role	What they receive
linagliptin 5 mg	Experimental	open label Receives: Drug: linagliptine 5 mg
linagliptin 5 mg and pioglitazone 30 mg	Experimental	open label Receives: Drug: linagliptine 5 mg and pioglitazone 30 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Patients With Adverse Events (AEs)
This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
Measured: 78 weeks
Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events
Measured: 78 weeks
Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)
As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis'').
Measured: 78 weeks
Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events
Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)
Measured: 78 weeks
Number of Patients With Abnormalities in Vital Signs
Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)
Measured: 78 weeks
Number of Patients With Abnormalities in Haematology: Eosinophils
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.
Measured: 78 weeks
Number of Patients With Abnormalities in Haematology: Haemoglobin
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients.
Measured: 78 weeks
Number of Patients With Abnormalities in Haematology: Haematocrit
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.
Measured: 78 weeks
Number of Patients With Abnormalities in Haematology: Red Blood Cell Count
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^12/L.
Measured: 78 weeks
Number of Patients With Abnormalities in Haematology: White Blood Cell Count
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^9/L (decrease) or a value greater than 20.1 * 10^9/L (increase).
Measured: 78 weeks
Number of Patients With Abnormalities in Haematology: Platelets
For this laboratory parameter, a possibly clinically significant abnormality is defined as value less than or equal to 75 * 10^9/L (decrease) or a value greater than or equal to 700 * 10^9/L (increase).
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Potassium
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase).
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients.
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Amylase
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN).
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT)
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Creatinine
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL.
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Phosphate
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase).
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Calcium
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase).
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Sodium
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 130 mmol/L (decrease) or a value greater than 160 mmol/L (increase).
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Glucose
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL.
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL.
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN.
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Albumin
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL.
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Measured: 78 weeks
Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.
Measured: 78 weeks

Secondary outcomes (17)

Change in HbA1c From Baseline to Week 6
Measured: Baseline and week 6
Change in HbA1c From Baseline to Week 18
Measured: Baseline and week 18
Change in HbA1c From Baseline to Week 30
Measured: Baseline and week 30
Change in HbA1c From Baseline to Week 42
Measured: Baseline and week 42
Change in HbA1c From Baseline to Week 54
Measured: Baseline and week 54
Change in HbA1c From Baseline to Week 66
Measured: Baseline and week 66
Change in HbA1c From Baseline to Week 78
Measured: Baseline and week 78
Number of Patients With HbA1c<7.0% Over Time
Measured: 78 weeks
Number of Patients With HbA1c<6.5% Over Time
Measured: 78 weeks
Number of Patients With Lowered HbA1c by at Least 0.5% Over Time
Measured: 78 weeks
Change in FPG From Baseline to Week 6
Measured: Baseline and week 6
Change in FPG From Baseline to Week 18
Measured: Baseline and week 18
Change in FPG From Baseline to Week 30
Measured: Baseline and week 30
Change in FPG From Baseline to Week 42
Measured: Baseline and week 42
Change in FPG From Baseline to Week 54
Measured: Baseline and week 54
Change in FPG From Baseline to Week 66
Measured: Baseline and week 66
Change in FPG From Baseline to Week 78
Measured: Baseline and week 78

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Dec 2010

First posted15 Aug 2008 (estimated)
Study startAug 2008
Primary completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2,122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00736099
Sponsor's protocol ID: 1218.40
Other IDs: 2008-000750-13, 2008
Status last verified: Dec 2013
First submitted: 14 Aug 2008
Last updated: 27 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingPhase 3
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Not yet recruiting
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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 1356 (5 mg) as Monotherapy or in Combination With Other Antidiabetic Medications in Type 2 Diabetic Patients.
ClinicalTrials.gov ID: NCT00736099
Acronym / sponsor ID: 1218.40
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,122 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Dec 2010 (actual)
First posted: 15 Aug 2008 (estimated)
Results: Posted 8 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
linagliptin 5 mg	Experimental	Drug: linagliptine 5 mgopen label
linagliptin 5 mg and pioglitazone 30 mg	Experimental	Drug: linagliptine 5 mg and pioglitazone 30 mgopen label

Who may qualify

Ages: 18 to 82 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Signed and dated written informed consent in accordance with the GCP and local legislation.
Patients completing the entire treatment period as a double blind trial whether or not they have been treated with rescue medication.

Key exclusion criteria (7 listed)

Patients who meet one or more of the withdrawal criteria of the treatment period of the previous trial.
Pre-menopausal women (last menstruation =< 1 year prior to signing informed consent) who:
Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation.
Drug abuse which, in the opinion of the investigator, would interfere with trial participation.
Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
linagliptine 5 mgsafety and efficacy of linagliptine 5 mg open label	Drug	linagliptin 5 mg
linagliptine 5 mg and pioglitazone 30 mgefficacy and safety of the combination linagliptine and pioglitazone	Drug	linagliptin 5 mg and pioglitazone 30 mg

Primary outcome

Frequency of Patients With Adverse Events (AEs)
Time frame: 78 weeks
This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events
Time frame: 78 weeks
Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)
Time frame: 78 weeks
As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis'').
Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events
Time frame: 78 weeks
Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)
Number of Patients With Abnormalities in Vital Signs
Time frame: 78 weeks
Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)
Number of Patients With Abnormalities in Haematology: Eosinophils
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.
Number of Patients With Abnormalities in Haematology: Haemoglobin
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients.
Number of Patients With Abnormalities in Haematology: Haematocrit
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.
Number of Patients With Abnormalities in Haematology: Red Blood Cell Count
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^12/L.
Number of Patients With Abnormalities in Haematology: White Blood Cell Count
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^9/L (decrease) or a value greater than 20.1 * 10^9/L (increase).
Number of Patients With Abnormalities in Haematology: Platelets
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as value less than or equal to 75 * 10^9/L (decrease) or a value greater than or equal to 700 * 10^9/L (increase).
Number of Patients With Abnormalities in Clinical Chemistry: Potassium
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase).
Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients.
Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.
Number of Patients With Abnormalities in Clinical Chemistry: Amylase
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN).
Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT)
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Number of Patients With Abnormalities in Clinical Chemistry: Creatinine
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL.
Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Number of Patients With Abnormalities in Clinical Chemistry: Phosphate
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase).
Number of Patients With Abnormalities in Clinical Chemistry: Calcium
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase).
Number of Patients With Abnormalities in Clinical Chemistry: Sodium
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 130 mmol/L (decrease) or a value greater than 160 mmol/L (increase).
Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Number of Patients With Abnormalities in Clinical Chemistry: Glucose
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL.
Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL.
Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN.
Number of Patients With Abnormalities in Clinical Chemistry: Albumin
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL.
Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol
Time frame: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.

17 secondary outcomes

Change in HbA1c From Baseline to Week 6
Time frame: Baseline and week 6
Change in HbA1c From Baseline to Week 18
Time frame: Baseline and week 18
Change in HbA1c From Baseline to Week 30
Time frame: Baseline and week 30
Change in HbA1c From Baseline to Week 42
Time frame: Baseline and week 42
Change in HbA1c From Baseline to Week 54
Time frame: Baseline and week 54
Change in HbA1c From Baseline to Week 66
Time frame: Baseline and week 66
Change in HbA1c From Baseline to Week 78
Time frame: Baseline and week 78
Number of Patients With HbA1c<7.0% Over Time
Time frame: 78 weeks
Number of Patients With HbA1c<6.5% Over Time
Time frame: 78 weeks
Number of Patients With Lowered HbA1c by at Least 0.5% Over Time
Time frame: 78 weeks
Change in FPG From Baseline to Week 6
Time frame: Baseline and week 6
Change in FPG From Baseline to Week 18
Time frame: Baseline and week 18
Change in FPG From Baseline to Week 30
Time frame: Baseline and week 30
Change in FPG From Baseline to Week 42
Time frame: Baseline and week 42
Change in FPG From Baseline to Week 54
Time frame: Baseline and week 54
Change in FPG From Baseline to Week 66
Time frame: Baseline and week 66
Change in FPG From Baseline to Week 78
Time frame: Baseline and week 78

Results and safety

Results posted to the registry on 8 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Old Lina	1,532	1,349
New Lina	589	531

Primary outcome: Frequency of Patients With Adverse Events (AEs)

Time frame: 78 weeks. Number. Unit: Participants

Measure	Old Lina n = 1532	New Lina n = 589
Patients with any AEs	1253	465
Patients with severe AEs	57	23
Patients with withdrawal due to AEs (from AE page)	57	16

Population analysed: Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.

Primary outcome: Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events

Time frame: 78 weeks. Number. Unit: Participants

Measure	Old Lina n = 1532	New Lina n = 589
Value	209	86

Population analysed: Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.

Primary outcome: Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)

Time frame: 78 weeks. Number. Unit: Participants

Measure	Old Lina n = 1532	New Lina n = 589
Renal AEs	20	10
Hypersensitivity reactions	7	3
Hepatic AEs	21	5
Severe cutaneous adverse reactions	0	0
Pancreatitis	4	0

Population analysed: Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.

Primary outcome: Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events

Time frame: 78 weeks. Number. Unit: participants

Measure	Old Lina n = 1532	New Lina n = 589
Value	82	37

Population analysed: Treated Set: all screened patients who were documented to have taken at least 1 dose of study drug

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: 78 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Old Lina	158 of 1,532 (10.3%)	784 of 1,532 (51.2%)	Not reported
New Lina	52 of 589 (8.8%)	285 of 589 (48.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Diabetes Mellitus, Type 2

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

232 sites in 32 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing linagliptine 5 mg and linagliptine 5 mg and pioglitazone 30 mg in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 232 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 232 sites in India, United States, Canada, China, Spain and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Patients With Adverse Events (AEs) (time frame: 78 weeks). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00736099.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2014.