AzTrials
AzTrials

Diabetes Mellitus Type 2Phase 3NCT00755287

A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.

A Phase 3 study testing insulin glargine, metformin and taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 210 sites in 27 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

This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus Type 2
What is being tested?
insulin glargine, metformin and taspoglutide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,072 participants
Where
210 sitesin 27 countries
Study dates
Nov 2008to Dec 2010
Phase
Phase 3
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients, 18-75 years of age;
  • type 2 diabetes treated with a stable dose of metformin and sulphonylurea for at least 12 weeks;
  • C-peptide (fasting) >=1.0ng/mL;
  • HbA1c >=7.0% and <=10.0% at screening;
  • BMI >=25 (>23 for Asians) and <=45kg/m2 at screening;
  • stable weight +-5% for at least 12 weeks prior to screening.

Who cannot join

  • history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
  • evidence of clinically significant diabetic complications;
  • symptomatic poorly controlled diabetes;
  • clinically symptomatic gastrointestinal disease;
  • myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
  • known hemoglobinopathy or chronic anemia.

Trial locations and contacts

210 sites in 27 countries.

210 sites in 27 countries

United States74 sites

  • Study site

    Albany, New York, 12206-1098

  • Study site

    Altoona, Pennsylvania, 16602

  • Study site

    Arkansas City, Kansas, 67005

  • Study site

    Asheville, North Carolina, 28803

  • Study site

    Atlanta, Georgia, 30338

  • Study site

    Avon, Indiana, 46123

  • Study site

    Bensalem, Pennsylvania, 19020

  • Study site

    Blackwood, New Jersey, 08012

  • Study site

    Centerville, Ohio, 45459

  • Study site

    Cherry Hill, New Jersey, 08002

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Concord, California, 94520

  • Study site

    Crestview Hills, Kentucky, 41017

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dallas, Texas, 75246

  • Study site

    Dallas, Texas, 75390

  • Study site

    Fargo, North Dakota, 58103

  • Study site

    Feasterville, Pennsylvania, 19053

  • Study site

    Flushing, New York, 11365

  • Study site

    Genoa, Ohio, 43430-1143

  • Study site

    Grand Island, Nebraska, 68803

  • Study site

    Green Cove Springs, Florida, 32043

  • Study site

    Harrisburg, North Carolina, 28075

  • Study site

    Harrisburg, Pennsylvania, 17112

  • Study site

    Henderson, Nevada, 89014

  • Study site

    Hialeah, Florida, 33013

  • Study site

    Houston, Texas, 77024

  • Study site

    Houston, Texas, 77030

  • Study site

    Huntington Beach, California, 92648

  • Study site

    Indianapolis, Indiana, 46260

  • Study site

    Jackson, Mississippi, 39216

  • Study site

    Jacksonville, Florida, 32204

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Jefferson Hills, Pennsylvania, 15025

  • Study site

    Johnson City, Tennessee, 37604

  • Study site

    Los Angeles, California, 90015

  • Study site

    Los Angeles, California, 90025

  • Study site

    Los Gatos, California, 95032

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Mineola, New York, 11501

  • Study site

    Moorestown, New Jersey, 08057

  • Study site

    North East, Maryland, 21901

  • Study site

    Omaha, Nebraska, 68105

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Orangeburg, South Carolina, 29115

  • Study site

    Ormond Beach, Florida, 32174

  • Study site

    Oviedo, Florida, 32765

  • Study site

    Palm Harbor, Florida, 34684

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Philadelphia, Pennsylvania, 19146

  • Study site

    Phoenix, Arizona, 85032

  • Study site

    Picayune, Mississippi, 39466

  • Study site

    Portland, Maine, 04101

  • Study site

    Quincy, Illinois, 62301

  • Study site

    Richmond, Virginia, 23249

  • Study site

    Roseville, California, 95661

  • Study site

    Saint Claire Shores, Michigan, 48081

  • Study site

    San Diego, California, 92109

  • Study site

    Santa Ana, California, 92705

  • Study site

    Scranton, Pennsylvania, 18510

  • Study site

    Searcy, Arkansas, 72143

  • Study site

    Springfield, Illinois, 62704-1433

  • Study site

    Springfield, Missouri, 65807

  • Study site

    Sunset, Louisiana, 70584

  • Study site

    Tipton, Pennsylvania, 16684

  • Study site

    Toledo, Ohio, 43606

  • Study site

    Toms River, New Jersey, 08753

  • Study site

    Toms River, New Jersey, 08755

  • Study site

    Trinity, Florida, 34655

  • Study site

    Washington D.C., District of Columbia, 20010

  • Study site

    Waukesha, Wisconsin, 53189

  • Study site

    Westlake Village, California, 91361

  • Study site

    Worchester, Massachusetts, 01605

  • Study site

    Zephyrhills, Florida, 33542

Other trials in United States

France15 sites

  • Study site

    Avignon, 84902

  • Study site

    Besançon, 25030

  • Study site

    Bois-Guillaume, 76233

  • Study site

    Brest, 29609

  • Study site

    Corbeil-Essonnes, 91106

  • Study site

    La Rochelle, 17019

  • Study site

    Marseille, 13015

  • Study site

    Marseille, 13385

  • Study site

    Montpellier, 34295

  • Study site

    Nîmes, 30029

  • Study site

    Paris, 75651

  • Study site

    Paris, 75877

  • Study site

    Paris, 75908

  • Study site

    Strasbourg, 67091

  • Study site

    Vénissieux, 69200

Other trials in France

Russia14 sites

  • Study site

    Barnaul, 656024

  • Study site

    Chelyabinsk, 454136

  • Study site

    Moscow, 117049

  • Study site

    Moscow, 125299

  • Study site

    Moscow, 129110

  • Study site

    Nizhny Novgorod, 603126

  • Study site

    Novosibirsk, 630047

  • Study site

    Omsk, 644021

  • Study site

    Saint Petersburg, 193012

  • Study site

    Saint Petersburg, 194291

  • Study site

    Saint Petersburg, 194354

  • Study site

    Saint Petersburg, 195213

  • Study site

    Saint Petersburg, 197022

  • Study site

    Tomsk, 643050

Other trials in Russia

Germany11 sites

  • Study site

    Bad Lauterberg im Harz, 37431

  • Study site

    Berlin, 10115

  • Study site

    Bochum, 44869

  • Study site

    Bosenheim, 55545

  • Study site

    Dortmund, 44137

  • Study site

    Falkensee, 14612

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Mainz, 55116

  • Study site

    Offenbach a.M., 63065

  • Study site

    Reichenbach, 08468

  • Study site

    Würzburg, 97072

Other trials in Germany

Spain10 sites

  • Study site

    Almería, Almeria, 04001

  • Study site

    Alzira, Valencia, 46600

  • Study site

    Barcelona, Barcelona, 08025

  • Study site

    Granada, Granada, 18012

  • Study site

    Pozuelo de Alarcón, Madrid, 28223

  • Study site

    Seville, Sevilla, 41010

  • Study site

    Seville, Sevilla, 41013

  • Study site

    Valencia, Valencia, 46010

  • Study site

    Valencia, Valencia, 46014

  • Study site

    Valladolid, Valladolid, 47005

Other trials in Spain

Poland7 sites

  • Study site

    Grodzisk Mazowiecki, 05-825

  • Study site

    Kamieniec Ząbkowicki, 57-230

  • Study site

    Lodz, 93-338

  • Study site

    Rzeszów, 35-073

  • Study site

    Sobótka, 55-050

  • Study site

    Szczecin, 71-455

  • Study site

    Wroclaw, 51-124

Other trials in Poland

Canada6 sites

  • Study site

    Hamilton, Ontario, L8S 4J9

  • Study site

    London, Ontario, N6A 5R8

  • Study site

    Pointe-Claire, Quebec, H9R 4S3

  • Study site

    Sherbrooke, Quebec, J1G 5K2

  • Study site

    Toronto, Ontario, M5G 2C4

  • Study site

    Vancouver, British Columbia, V5Z 1L8

Other trials in Canada

Italy6 sites

  • Study site

    Codogno, Lombardy, 26845

  • Study site

    Milan, Lombardy, 20132

  • Study site

    Milan, Lombardy, 20142

  • Study site

    Naples, Campania, 80100

  • Study site

    Rome, Lazio, 00157

  • Study site

    Turin, Piedmont, 10126

Other trials in Italy

Puerto Rico6 sites

  • Study site

    Guyanabo, San Juan, 00920

  • Study site

    Levittown, 00950

  • Study site

    Orocovis, 00720

  • Study site

    Ponce, 00717-322

  • Study site

    San Juan, 00926-2832

  • Study site

    Trujillo Alto, 00976

Other trials in Puerto Rico

United Kingdom6 sites

  • Study site

    Atherstone, CV9 1EU

  • Study site

    Chesterfield, S40 4TF

  • Study site

    Dumfries, DG1 4AP

  • Study site

    Liverpool, L9 7AL

  • Study site

    Sheffield, S18 1RU

  • Study site

    Trowbridge, BA14 8QA

Other trials in United Kingdom

Austria5 sites

  • Study site

    Graz, 8036

  • Study site

    Salzburg, 5020

  • Study site

    Vienna, 1030

  • Study site

    Vienna, 1080

  • Study site

    Vienna, 1130

Other trials in Austria

Brazil5 sites

  • Study site

    Campina Grande do Sul, Paraná, 83430-000

  • Study site

    Curitiba, Paraná, 80030-110

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-170

  • Study site

    Recife, Pernambuco, 52051-380

  • Study site

    São Paulo, São Paulo, 04022-001

Other trials in Brazil

Czechia5 sites

  • Study site

    Brno, 625 00

  • Study site

    Havířov, 76301

  • Study site

    Pilsen, 301 00

  • Study site

    Prague, 180 00

  • Study site

    Trutnov, 541 01

Other trials in Czechia

Belgium4 sites

  • Study site

    Arlon, 6700

  • Study site

    Bonheiden, 2820

  • Study site

    Leuven, 3000

  • Study site

    Liège, 4000

Other trials in Belgium

Mexico4 sites

  • Study site

    Aguascalientes, 20127

  • Study site

    Cuernavaca, 62250

  • Study site

    Monterrey, 64410

  • Study site

    Tampico, 89000

Other trials in Mexico

Peru4 sites

  • Study site

    Arequipa, Cercado

  • Study site

    Lima, Lima 1

  • Study site

    Lima, Lima 33

  • Study site

    Trujillo, 13011

Other trials in Peru

Serbia4 sites

  • Study site

    Belgrade, 11000

  • Study site

    Kragujevac, 34000

  • Study site

    Niš, 18000

  • Study site

    Novi Sad, 21000

Other trials in Serbia

Australia3 sites

  • Study site

    Freemantle, Queensland, 6959

  • Study site

    St Leonards, New South Wales, 2065

  • Study site

    Wollongong, New South Wales, 2500

Other trials in Australia

Finland3 sites

  • Study site

    Helsinki, 00150

  • Study site

    Jyväskylä, 40100

  • Study site

    Tampere, 33100

Other trials in Finland

Greece3 sites

  • Study site

    Athens, 10552

  • Study site

    Larissa, 41110

  • Study site

    Thessaloniki, 56429

Other trials in Greece

Hungary3 sites

  • Study site

    Balatonfüred, 8230

  • Study site

    Budapest, 1045

  • Study site

    Szekszárd, 7100

Other trials in Hungary

Portugal3 sites

  • Study site

    Coimbra, 3000-075

  • Study site

    Lisbon, 1250-203

  • Study site

    Lisbon, 1349-019

Other trials in Portugal

South Korea3 sites

  • Study site

    Daegu, 700-721

  • Study site

    Incheon

  • Study site

    Seoul, 137-040

Other trials in South Korea

New Zealand2 sites

  • Study site

    Auckland, 1640

  • Study site

    Auckland

Other trials in New Zealand

Thailand2 sites

  • Study site

    Bangkok, 10330

  • Study site

    Bangkok, 10400

Other trials in Thailand

Guatemala1 site

  • Study site

    Guatemala City, 01010

Other trials in Guatemala

Hong Kong1 site

  • Study site

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Multicenter, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naïve Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy

This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals.

Being tested
insulin glargine, metformin, taspoglutide
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.

  • insulin glargineDrug

    starting dose 10 IU daily

  • metforminDrug

    As prescribed

  • taspoglutideDrug

    10 mg once weekly

  • taspoglutideDrug

    20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly)

Study groups in NCT00755287
Study groupRoleWhat they receive
insulin glargineActive comparatorinsulin glargine starting dose 10 IU daily in addition to continued prestudy metformin treatment
Receives: Drug: insulin glargine; Drug: metformin
taspoglutide 10 mgExperimentaltaspoglutide 10 mg once weekly in addition to continued prestudy metformin treatment
Receives: Drug: metformin; Drug: taspoglutide
taspoglutide 10 mg/20 mgExperimentaltaspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued prestudy metformin treatment
Receives: Drug: metformin; Drug: taspoglutide

What is being measured

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

  1. Absolute change from baseline in HbA1c

    Measured: 24 weeks

Secondary outcomes (3)

  1. Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); incidence of hypoglycemia; change from baseline in lipid profile.

    Measured: 24 weeks

  2. Relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test.

    Measured: 24 weeks

  3. Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies

    Measured: Throughout study

Timeline

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

  1. First posted18 Sep 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

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
None (open label)
Enrolment
1,072 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00755287
Sponsor's protocol ID
BC20965
Other IDs
2008-001855-23, 2008
Status last verified
Jul 2016
First submitted
17 Sep 2008
Last updated
29 Jul 2016
Results posted
No

Publications

  • Nauck M, Horton E, Andjelkovic M, Ampudia-Blasco FJ, Parusel CT, Boldrin M, Balena R; T-emerge 5 Study Group. Taspoglutide, a once-weekly glucagon-like peptide 1 analogue, vs. insulin glargine titrated to target in patients with Type 2 diabetes: an open-label randomized trial. Diabet Med. 2013 Jan;30(1):109-13. doi: 10.1111/dme.12003.

    PubMed 22937895

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin glargine, metformin and taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 210 sites in 27 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 6 inclusion and 6 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 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 210 sites in United States, France, Russia, Germany, Spain and 22 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Absolute change from baseline in HbA1c (time frame: 24 weeks). 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 NCT00755287, which also lists 1 linked publication.

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 Jul 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in