Diabetes Mellitus, Type 2Phase 3NCT00622284

Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes

A Phase 3 study testing BI 1356 and Glimepiride in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 221 sites in 16 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 efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably > 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: BI 1356 and Glimepiride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,560 participants
Where: 221 sitesin 16 countries
Study dates: Feb 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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone
HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase

Who cannot join

Myocardial infarction, stroke or transient ischemic attack (TIA)
Impaired hepatic function
Renal failure or renal impairment
Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within 3 months prior to screening

Trial locations and contacts

221 sites in 16 countries.

Country

City, postcode or hospital

221 sites in 16 countries

France74 sites

1218.20.3308A Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3308C Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3308D Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3308E Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3308F Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3309A Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3309B Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3309C Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3309D Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3309E Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3311A Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3311B Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3311C Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3313A Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3313B Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3313C Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3313D Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3314A Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3314B Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3314C Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3314D Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3314E Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3314F Boehringer Ingelheim Investigational Site
Joué Les Tours
1218.20.3307A Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3307B Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3307C Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3307D Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3307E Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3307F Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3307G Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3307H Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3307I Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3310A Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3310B Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3310C Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3310D Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3310E Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3312A Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3312B Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3312C Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3312D Boehringer Ingelheim Investigational Site
Joué Les Tours Cedex
1218.20.3301A Boehringer Ingelheim Investigational Site
Nantes
1218.20.3302A Boehringer Ingelheim Investigational Site
Nantes
1218.20.3302C Boehringer Ingelheim Investigational Site
Nantes
1218.20.3302D Boehringer Ingelheim Investigational Site
Nantes
1218.20.3302E Boehringer Ingelheim Investigational Site
Nantes
1218.20.3302G Boehringer Ingelheim Investigational Site
Nantes
1218.20.3302H Boehringer Ingelheim Investigational Site
Nantes
1218.20.3302I Boehringer Ingelheim Investigational Site
Nantes
1218.20.3303A Boehringer Ingelheim Investigational Site
Nantes
1218.20.3303B Boehringer Ingelheim Investigational Site
Nantes
1218.20.3303C Boehringer Ingelheim Investigational Site
Nantes
1218.20.3303D Boehringer Ingelheim Investigational Site
Nantes
1218.20.3303E Boehringer Ingelheim Investigational Site
Nantes
1218.20.3303G Boehringer Ingelheim Investigational Site
Nantes
1218.20.3303H Boehringer Ingelheim Investigational Site
Nantes
1218.20.3303I Boehringer Ingelheim Investigational Site
Nantes
1218.20.3304A Boehringer Ingelheim Investigational Site
Nantes
1218.20.3304B Boehringer Ingelheim Investigational Site
Nantes
1218.20.3304C Boehringer Ingelheim Investigational Site
Nantes
1218.20.3304D Boehringer Ingelheim Investigational Site
Nantes
1218.20.3304F Boehringer Ingelheim Investigational Site
Nantes
1218.20.3304H Boehringer Ingelheim Investigational Site
Nantes
1218.20.3305A Boehringer Ingelheim Investigational Site
Nantes
1218.20.3305B Boehringer Ingelheim Investigational Site
Nantes
1218.20.3305H Boehringer Ingelheim Investigational Site
Nantes
1218.20.3306A Boehringer Ingelheim Investigational Site
Nantes
1218.20.3306B Boehringer Ingelheim Investigational Site
Nantes
1218.20.3306D Boehringer Ingelheim Investigational Site
Nantes
1218.20.3306F Boehringer Ingelheim Investigational Site
Nantes
1218.20.3306G Boehringer Ingelheim Investigational Site
Nantes
1218.20.3306H Boehringer Ingelheim Investigational Site
Nantes
1218.20.3306I Boehringer Ingelheim Investigational Site
Nantes
1218.20.3311D Boehringer Ingelheim Investigational Site
Potigny

Other trials in France

Germany28 sites

1218.20.49004 Boehringer Ingelheim Investigational Site
Aschaffenburg
1218.20.49028 Boehringer Ingelheim Investigational Site
Bad Mergentheim
1218.20.49022 Boehringer Ingelheim Investigational Site
Berlin
1218.20.49024 Boehringer Ingelheim Investigational Site
Bosenheim
1218.20.49012 Boehringer Ingelheim Investigational Site
Cologne
1218.20.49020 Boehringer Ingelheim Investigational Site
Dresden
1218.20.49018 Boehringer Ingelheim Investigational Site
Flörsheim
1218.20.49015 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1218.20.49006 Boehringer Ingelheim Investigational Site
Großheirath
1218.20.49025 Boehringer Ingelheim Investigational Site
Haag
1218.20.49016 Boehringer Ingelheim Investigational Site
Hamburg
1218.20.49029 Boehringer Ingelheim Investigational Site
Hanover
1218.20.49021 Boehringer Ingelheim Investigational Site
Hatten
1218.20.49017 Boehringer Ingelheim Investigational Site
Kelkheim
1218.20.49005 Boehringer Ingelheim Investigational Site
Künzing
1218.20.49010 Boehringer Ingelheim Investigational Site
Leipzig
1218.20.49003 Boehringer Ingelheim Investigational Site
Neuwied
1218.20.49007 Boehringer Ingelheim Investigational Site
Nuremberg
1218.20.49008 Boehringer Ingelheim Investigational Site
Rednitzhembach
1218.20.49027 Boehringer Ingelheim Investigational Site
Saaldorf
1218.20.49014 Boehringer Ingelheim Investigational Site
Saarbrücken
1218.20.49019 Boehringer Ingelheim Investigational Site
Saint Ingbert/Oberwürzbach
1218.20.49030 Boehringer Ingelheim Investigational Site
Speyer
1218.20.49002 Boehringer Ingelheim Investigational Site
Sulzbach-Rosenberg
1218.20.49009 Boehringer Ingelheim Investigational Site
Unterschneidheim
1218.20.49026 Boehringer Ingelheim Investigational Site
Wangen
1218.20.49011 Boehringer Ingelheim Investigational Site
Westerkappeln
1218.20.49013 Boehringer Ingelheim Investigational Site
Würzburg

Other trials in Germany

United States23 sites

1218.20.10003 Boehringer Ingelheim Investigational Site
Chula Vista, California
1218.20.10032 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1218.20.10031 Boehringer Ingelheim Investigational Site
Columbus, Ohio
1218.20.10022 Boehringer Ingelheim Investigational Site
Endwell, New York
1218.20.10009 Boehringer Ingelheim Investigational Site
Federal Way, Washington
1218.20.10002 Boehringer Ingelheim Investigational Site
Greer, South Carolina
1218.20.10023 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
1218.20.10020 Boehringer Ingelheim Investigational Site
Los Angeles, California
1218.20.10035 Boehringer Ingelheim Investigational Site
Los Angeles, California
1218.20.10037 Boehringer Ingelheim Investigational Site
Los Gatos, California
1218.20.10013 Boehringer Ingelheim Investigational Site
Mentor, Ohio
1218.20.10036 Boehringer Ingelheim Investigational Site
Murray, Utah
1218.20.10042 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
1218.20.10006 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
1218.20.10045 Boehringer Ingelheim Investigational Site
Perrysburg, Ohio
1218.20.10024 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1218.20.10026 Boehringer Ingelheim Investigational Site
Renton, Washington
1218.20.10029 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
1218.20.10007 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1218.20.10028 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1218.20.10033 Boehringer Ingelheim Investigational Site
Tempe, Arizona
1218.20.10030 Boehringer Ingelheim Investigational Site
Topeka, Kansas
1218.20.10034 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida

Other trials in United States

United Kingdom16 sites

1218.20.44108 Boehringer Ingelheim Investigational Site
Baillieston, Glasgow
1218.20.44115 Boehringer Ingelheim Investigational Site
Blackpool
1218.20.44110 Boehringer Ingelheim Investigational Site
Bradford on Avon
1218.20.44102 Boehringer Ingelheim Investigational Site
Buckshaw Village, Chorley
1218.20.44114 Boehringer Ingelheim Investigational Site
Cheadle
1218.20.44116 Boehringer Ingelheim Investigational Site
Chestfield, Whitstable
1218.20.44109 Boehringer Ingelheim Investigational Site
Chippenham
1218.20.44113 Boehringer Ingelheim Investigational Site
Dundee
1218.20.44105 Boehringer Ingelheim Investigational Site
Edgbaston, Birmingham
1218.20.44112 Boehringer Ingelheim Investigational Site
Ely
1218.20.44101 Boehringer Ingelheim Investigational Site
Guildford
1218.20.44103 Boehringer Ingelheim Investigational Site
Manchester
1218.20.44106 Boehringer Ingelheim Investigational Site
Trowbridge
1218.20.44104 Boehringer Ingelheim Investigational Site
Waterloo, Liverpool
1218.20.44111 Boehringer Ingelheim Investigational Site
Westbury
1218.20.44107 Boehringer Ingelheim Investigational Site
Whitstable

Other trials in United Kingdom

Italy10 sites

1218.20.39034 Boehringer Ingelheim Investigational Site
Catania
1218.20.39027 Boehringer Ingelheim Investigational Site
Chieti
1218.20.39029 Boehringer Ingelheim Investigational Site
Codogno (lo)
1218.20.39021 Boehringer Ingelheim Investigational Site
Genova
1218.20.39033 Boehringer Ingelheim Investigational Site
Perugia
1218.20.39022 Boehringer Ingelheim Investigational Site
Pordenone
1218.20.39028 Boehringer Ingelheim Investigational Site
Ravenna
1218.20.39030 Boehringer Ingelheim Investigational Site
Roma
1218.20.39032 Boehringer Ingelheim Investigational Site
Roma
1218.20.39020 Boehringer Ingelheim Investigational Site
Siena

Other trials in Italy

Netherlands9 sites

1218.20.31023 Boehringer Ingelheim Investigational Site
's-Hertogenbosch
1218.20.31014 Boehringer Ingelheim Investigational Site
Almere Stad
1218.20.31016 Boehringer Ingelheim Investigational Site
Beek en Donk
1218.20.31011 Boehringer Ingelheim Investigational Site
Ewijk
1218.20.31018 Boehringer Ingelheim Investigational Site
Hoogwoud
1218.20.31012 Boehringer Ingelheim Investigational Site
Oude Pekela
1218.20.31022 Boehringer Ingelheim Investigational Site
Rilland
1218.20.31019 Boehringer Ingelheim Investigational Site
Roelofarendsveen
1218.20.31013 Boehringer Ingelheim Investigational Site
Wildervank

Other trials in Netherlands

Poland9 sites

1218.20.48210 Boehringer Ingelheim Investigational Site
Bialystok
1218.20.48208 Boehringer Ingelheim Investigational Site
Gdynia
1218.20.48207 Boehringer Ingelheim Investigational Site
Krakow
1218.20.48201 Boehringer Ingelheim Investigational Site
Lodz
1218.20.48202 Boehringer Ingelheim Investigational Site
Lodz
1218.20.48203 Boehringer Ingelheim Investigational Site
Olsztyn
1218.20.48206 Boehringer Ingelheim Investigational Site
Torun
1218.20.48205 Boehringer Ingelheim Investigational Site
Warsaw
1218.20.48209 Boehringer Ingelheim Investigational Site
Warsaw

Other trials in Poland

Hungary8 sites

1218.20.36208 Boehringer Ingelheim Investigational Site
Ajka
1218.20.36205 Boehringer Ingelheim Investigational Site
Baja
1218.20.36204 Boehringer Ingelheim Investigational Site
Békéscsaba
1218.20.36206 Boehringer Ingelheim Investigational Site
Hódmezövásárhely
1218.20.36202 Boehringer Ingelheim Investigational Site
Makó
1218.20.36201 Boehringer Ingelheim Investigational Site
Miskolc
1218.20.36207 Boehringer Ingelheim Investigational Site
Mosonmagyaróvár
1218.20.36203 Boehringer Ingelheim Investigational Site
Szentes

Other trials in Hungary

India8 sites

1218.20.91022 Boehringer Ingelheim Investigational Site
Chennai
1218.20.91024 Boehringer Ingelheim Investigational Site
Coimbatore
1218.20.91025 Boehringer Ingelheim Investigational Site
Gujarat
1218.20.91023 Boehringer Ingelheim Investigational Site
Hyderabad
1218.20.91021 Boehringer Ingelheim Investigational Site
Kochi
1218.20.91020 Boehringer Ingelheim Investigational Site
Mumbai
1218.20.91027 Boehringer Ingelheim Investigational Site
Patna
1218.20.91026 Boehringer Ingelheim Investigational Site
Tamilnadu

Other trials in India

Denmark7 sites

1218.20.45006 Boehringer Ingelheim Investigational Site
Aalborg
1218.20.45001 Boehringer Ingelheim Investigational Site
Aarhus C
1218.20.45011 Boehringer Ingelheim Investigational Site
Aarhus C
1218.20.45013 Boehringer Ingelheim Investigational Site
Aarhus C
1218.20.45002 Boehringer Ingelheim Investigational Site
Hvidovre
1218.20.45003 Boehringer Ingelheim Investigational Site
København NV
1218.20.45007 Boehringer Ingelheim Investigational Site
Odense

Other trials in Denmark

Ireland6 sites

1218.20.35307 Boehringer Ingelheim Investigational Site
Co. Cork
1218.20.35304 Boehringer Ingelheim Investigational Site
Co. Wexford
1218.20.35306 Boehringer Ingelheim Investigational Site
Co. Wexford
1218.20.35310 Boehringer Ingelheim Investigational Site
Co. Wexford
1218.20.35308 Boehringer Ingelheim Investigational Site
Dublin
1218.20.35303 Boehringer Ingelheim Investigational Site
Waterford

Other trials in Ireland

South Africa6 sites

1218.20.27007 Boehringer Ingelheim Investigational Site
Bellville
1218.20.27002 Boehringer Ingelheim Investigational Site
Cape Town
1218.20.27006 Boehringer Ingelheim Investigational Site
Durban
1218.20.27004 Boehringer Ingelheim Investigational Site
Lenasia
1218.20.27005 Boehringer Ingelheim Investigational Site
Lenasia
1218.20.27003 Boehringer Ingelheim Investigational Site
Pretoria

Other trials in South Africa

Bulgaria5 sites

1218.20.35201 Boehringer Ingelheim Investigational Site
Sofia
1218.20.35202 Boehringer Ingelheim Investigational Site
Sofia
1218.20.35203 Boehringer Ingelheim Investigational Site
Sofia
1218.20.35207 Boehringer Ingelheim Investigational Site
Sofia
1218.20.35204 Boehringer Ingelheim Investigational Site
Stara Zagora

Other trials in Bulgaria

Norway5 sites

1218.20.47005 Boehringer Ingelheim Investigational Site
Fevik
1218.20.47004 Boehringer Ingelheim Investigational Site
Fornebu
1218.20.47002 Boehringer Ingelheim Investigational Site
Hamar
1218.20.47001 Boehringer Ingelheim Investigational Site
Rud
1218.20.47003 Boehringer Ingelheim Investigational Site
Sandvika

Other trials in Norway

Sweden4 sites

1218.20.46003 Boehringer Ingelheim Investigational Site
Gothenburg
1218.20.46001 Boehringer Ingelheim Investigational Site
Malmö
1218.20.46002 Boehringer Ingelheim Investigational Site
Malmö
1218.20.46004 Boehringer Ingelheim Investigational Site
Uppsala

Other trials in Sweden

Hong Kong3 sites

1218.20.85201 Boehringer Ingelheim Investigational Site
Hong Kong
1218.20.85202 Boehringer Ingelheim Investigational Site
Hong Kong
1218.20.85204 Boehringer Ingelheim Investigational Site
Hong Kong

Other trials in Hong Kong

About this study

Official title: A Randomised Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 1356 ( 5.0 mg, Administered Orally Once Daily) Compared to Glimepiride Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

Conditions: Diabetes Mellitus, Type 2
Being tested: Placebo identical to BI 1356 5mg, Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg, BI 1356, Glimepiride
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.

Placebo identical to BI 1356 5mgDrug
Placebo tablet once daily
Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mgDrug
Placebo tablets once daily
BI 1356Drug
5mg, once daily in the morning for 104 weeks
GlimepirideDrug
1mg or 2mg or 3mg or 4mg in the morning for 104 weeks

Study groups in NCT00622284
Study group	Role	What they receive
BI 1356 5mg, once daily	Experimental	patient to receive a tablet containing 5mg BI 1356 plus one (two in US) inactive placebo capsule matching Glimepiride Receives: Drug: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg; Drug: BI 1356
Glimepiride	Active comparator	patient to receive 1mg or 2mg or 3mg (not in US) or 4mg Glimepiride capsule plus one inactive placebo tablet matching BI 1356 (plus one inactive placebo capsule in US) Receives: Drug: Placebo identical to BI 1356 5mg; Drug: Glimepiride

What is being measured

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

HbA1c Change From Baseline at Week 52
This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
Measured: Baseline and week 52
HbA1c Change From Baseline at Week 104
This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
Measured: Baseline and week 104

Secondary outcomes (27)

Body Weight Change From Baseline at Week 52
This key secondary endpoint, change from baseline, reflects the Week 52 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.
Measured: Baseline and week 52
Body Weight Change From Baseline at Week 104
This key secondary endpoint, change from baseline, reflects the Week 104 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.
Measured: Baseline and week 104
Incidence of Hypoglycaemic Events up to 52 Weeks
A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a home blood glucose monitoring (HBGM) of below 55 mg/dl (3.1 mmol/L)
Measured: Week 52
Incidence of Hypoglycaemic Events up to 104 Weeks
A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a HBGM of below 55 mg/dl (3.1 mmol/L)
Measured: Week 104
Fasting Plasma Glucose (FPG) Change From Baseline at Week 52
This change from baseline reflects the Week 52 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and the number of previous anti-diabetic medications.
Measured: Baseline and week 52
Fasting Plasma Glucose (FPG) Change From Baseline at Week 104
This change from baseline reflects the Week 104 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and number of previous anti-diabetic medications.
Measured: Baseline and week 104
Percentage of Patients With HbA1c <7.0% at Week 52
The percentage of patients with an HbA1c value below 7.0% at week 52, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Measured: Week 52
Percentage of Patients With HbA1c <7.0% at Week 104
The percentage of patients with an HbA1c value below 7.0% at week 104, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Measured: Week 104
Percentage of Patients With HbA1c <6.5% at Week 52
The percentage of patients with an HbA1c value below 6.5% at week 52, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Measured: Week 52
Percentage of Patients With HbA1c <6.5% at Week 104
The percentage of patients with an HbA1c value below 6.5% at week 104, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Measured: Week 104
Percentage of Patients With HbA1c Lowering by 0.5% at Week 104
Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104
Measured: Week 104
2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104
This change from baseline reflects the Week 104 2 hr PPG minus the Baseline 2hr PPG. Means are treatment adjusted for baseline HbA1c, baseline 2hr PPG and number of previous anti-diabetic medications.
Measured: Baseline and week 104
HbA1c Change at Week 4
Difference of base percent value [Week x(%) - baseline (%)]
Measured: Baseline and week 4
HbA1c Change at Week 8
Measured: Baseline and week 8
HbA1c Change at Week 12
Measured: Baseline and week 12
HbA1c Change at Week 16
Measured: Baseline and week 16
HbA1c Change at Week 28
Measured: Baseline and week 28
HbA1c Change at Week 40
Measured: Baseline and week 40
HbA1c Change at Week 52
Measured: Baseline and week 52
HbA1c Change at Week 65
Measured: Baseline and week 65
HbA1c Change at Week 78
Measured: Baseline and week 78
HbA1c Change at Week 91
Measured: Baseline and week 91
HbA1c Change at Week 104
The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as imputation rule.
Measured: Baseline and week 104
Change in Baseline Lipid Parameter Cholesterol at Week 104
Measured: Baseline and week 104
Change in Baseline Lipid Parameter HDL at Week 104
Measured: Baseline and week 104
Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104
Measured: Baseline and week 104
Change in Baseline Lipid Parameter Triglyceride at Week 104
Measured: Baseline and week 104

Timeline

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

Feb 2008Dec 2010

First posted25 Feb 2008 (estimated)
Study startFeb 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.
Publications (4)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 1,560 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00622284
Sponsor's protocol ID: 1218.20
Other IDs: 2007-004585-40
Status last verified: Dec 2013
First submitted: 13 Feb 2008
Last updated: 29 Jan 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Dennis JM, Young KG, Cardoso P, Gudemann LM, McGovern AP, Farmer A, Holman RR, Sattar N, McKinley TJ, Pearson ER, Jones AG, Shields BM, Hattersley AT; MASTERMIND Consortium. A five-drug class model using routinely available clinical features to optimise prescribing in type 2 diabetes: a prediction model development and validation study. Lancet. 2025 Mar 1;405(10480):701-714. doi: 10.1016/S0140-6736(24)02617-5. Epub 2025 Feb 25.
PubMed 40020703
Gallwitz B, Rosenstock J, Emser A, von Eynatten M, Woerle HJ. Linagliptin is more effective than glimepiride at achieving a composite outcome of target HbA(1)c < 7% with no hypoglycaemia and no weight gain over 2 years. Int J Clin Pract. 2013 Apr;67(4):317-21. doi: 10.1111/ijcp.12101.
PubMed 23521323
Gallwitz B, Rosenstock J, Rauch T, Bhattacharya S, Patel S, von Eynatten M, Dugi KA, Woerle HJ. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. Lancet. 2012 Aug 4;380(9840):475-83. doi: 10.1016/S0140-6736(12)60691-6. Epub 2012 Jun 28.
PubMed 22748821
Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.
PubMed 22234149

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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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 1356 ( 5.0 mg, Administered Orally Once Daily) Compared to Glimepiride Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
ClinicalTrials.gov ID: NCT00622284
Acronym / sponsor ID: 1218.20
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,560 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Dec 2010 (actual)
First posted: 25 Feb 2008 (estimated)
Results: Posted 20 Feb 2012

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
BI 1356 5mg, once daily	Experimental	Drug: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg, Drug: BI 1356patient to receive a tablet containing 5mg BI 1356 plus one (two in US) inactive placebo capsule matching Glimepiride
Glimepiride	Active comparator	Drug: Placebo identical to BI 1356 5mg, Drug: Glimepiridepatient to receive 1mg or 2mg or 3mg (not in US) or 4mg Glimepiride capsule plus one inactive placebo tablet matching BI 1356 (plus one inactive placebo capsule in US)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone
HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase

Key exclusion criteria (5 listed)

Myocardial infarction, stroke or transient ischemic attack (TIA)
Impaired hepatic function
Renal failure or renal impairment
Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within 3 months prior to screening

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
Placebo identical to BI 1356 5mgPlacebo tablet once daily	Drug	Glimepiride
Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mgPlacebo tablets once daily	Drug	BI 1356 5mg, once daily
BI 13565mg, once daily in the morning for 104 weeks	Drug	BI 1356 5mg, once daily
Glimepiride1mg or 2mg or 3mg or 4mg in the morning for 104 weeks	Drug	Glimepiride

Primary outcome

HbA1c Change From Baseline at Week 52
Time frame: Baseline and week 52
This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
HbA1c Change From Baseline at Week 104
Time frame: Baseline and week 104
This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.

27 secondary outcomes

Body Weight Change From Baseline at Week 52
Time frame: Baseline and week 52
Body Weight Change From Baseline at Week 104
Time frame: Baseline and week 104
Incidence of Hypoglycaemic Events up to 52 Weeks
Time frame: Week 52
Incidence of Hypoglycaemic Events up to 104 Weeks
Time frame: Week 104
Fasting Plasma Glucose (FPG) Change From Baseline at Week 52
Time frame: Baseline and week 52
Fasting Plasma Glucose (FPG) Change From Baseline at Week 104
Time frame: Baseline and week 104
Percentage of Patients With HbA1c <7.0% at Week 52
Time frame: Week 52
Percentage of Patients With HbA1c <7.0% at Week 104
Time frame: Week 104
Percentage of Patients With HbA1c <6.5% at Week 52
Time frame: Week 52
Percentage of Patients With HbA1c <6.5% at Week 104
Time frame: Week 104
Percentage of Patients With HbA1c Lowering by 0.5% at Week 104
Time frame: Week 104
2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104
Time frame: Baseline and week 104
HbA1c Change at Week 4
Time frame: Baseline and week 4
HbA1c Change at Week 8
Time frame: Baseline and week 8
HbA1c Change at Week 12
Time frame: Baseline and week 12
HbA1c Change at Week 16
Time frame: Baseline and week 16
HbA1c Change at Week 28
Time frame: Baseline and week 28
HbA1c Change at Week 40
Time frame: Baseline and week 40
HbA1c Change at Week 52
Time frame: Baseline and week 52
HbA1c Change at Week 65
Time frame: Baseline and week 65
HbA1c Change at Week 78
Time frame: Baseline and week 78
HbA1c Change at Week 91
Time frame: Baseline and week 91
HbA1c Change at Week 104
Time frame: Baseline and week 104
Change in Baseline Lipid Parameter Cholesterol at Week 104
Time frame: Baseline and week 104
Change in Baseline Lipid Parameter HDL at Week 104
Time frame: Baseline and week 104
Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104
Time frame: Baseline and week 104
Change in Baseline Lipid Parameter Triglyceride at Week 104
Time frame: Baseline and week 104

Results and safety

Results posted to the registry on 20 Feb 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
Linagliptin	776	587
Glimepiride	775	604

Primary outcome: HbA1c Change From Baseline at Week 52

Time frame: Baseline and week 52. Mean (Standard Error). Unit: Percent

Measure	Linagliptin n = 764	Glimepiride n = 755
Value	-0.36 (0.03)	-0.57 (0.03)

Linagliptin vs Glimepiride: Least Squares Mean Difference: 0.22 (97.5% CI 0.13 to 0.31), p = 0.0005, ANCOVA

Population analysed: The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.

Primary outcome: HbA1c Change From Baseline at Week 104

Time frame: Baseline and week 104. Mean (Standard Error). Unit: Percent

Measure	Linagliptin n = 764	Glimepiride n = 755
Value	-0.16 (0.03)	-0.36 (0.03)

Linagliptin vs Glimepiride: Least Squares Mean Difference: 0.20 (97.5% CI 0.09 to 0.30), p = 0.0004, ANCOVA

27 secondary outcomes are reported in the full results.

Adverse events

Time frame: From day of first dose until 7 days after last dose. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Linagliptin	135 of 776 (17.4%)	438 of 776 (56.4%)	Not reported
Glimepiride	162 of 775 (20.9%)	526 of 775 (67.9%)	Not reported

Limitations and caveats (from the sponsor): With the exception of HbA1c\<6.5% and HbA1c\<7.0% at Week52, all other endpoints are presented in the Week52 repeated analysis within the final clinical trial report, where discrepancies between interim and final results are also explained.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40020703Dennis JM, Young KG, Cardoso P, Gudemann LM, McGovern AP, Farmer A, Holman RR, Sattar N, McKinley TJ, Pearson ER, Jones AG, Shields BM, Hattersley AT; MASTERMIND Consortium. A five-drug class model using routinely available clinical features to optimise prescribing in type 2 diabetes: a prediction model development and validation study. Lancet. 2025 Mar 1;405(10480):701-714. doi: 10.1016/S0140-6736(24)02617-5. Epub 2025 Feb 25.
Derived from this study: PubMed 23521323Gallwitz B, Rosenstock J, Emser A, von Eynatten M, Woerle HJ. Linagliptin is more effective than glimepiride at achieving a composite outcome of target HbA(1)c < 7% with no hypoglycaemia and no weight gain over 2 years. Int J Clin Pract. 2013 Apr;67(4):317-21. doi: 10.1111/ijcp.12101.
Derived from this study: PubMed 22748821Gallwitz B, Rosenstock J, Rauch T, Bhattacharya S, Patel S, von Eynatten M, Dugi KA, Woerle HJ. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. Lancet. 2012 Aug 4;380(9840):475-83. doi: 10.1016/S0140-6736(12)60691-6. Epub 2012 Jun 28.
Derived from this study: PubMed 22234149Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

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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

221 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI 1356 and Glimepiride in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 221 sites in 16 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 4 inclusion and 5 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 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 221 sites in France, Germany, United States, United Kingdom, Italy and 11 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 20 Feb 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?

HbA1c Change From Baseline at Week 52 (time frame: Baseline and week 52). The study lists 2 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 NCT00622284, which also lists 4 linked publications.

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 29 Jan 2014.