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Diabetes Mellitus Type 2Phase 3NCT00754988

A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.

A Phase 3 study testing Metformin, Sitagliptin and Taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 148 sites in 23 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 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. 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?
Metformin, Sitagliptin and Taspoglutide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
666 participants
Where
148 sitesin 23 countries
Study dates
Oct 2008to Mar 2011
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 receiving metformin (>=1500mg/day) for at least 12 weeks;
  • 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;
  • 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

148 sites in 23 countries.

148 sites in 23 countries

United States64 sites

  • Study site

    Aliquippa, Pennsylvania, 15001

  • Study site

    Anderson, South Carolina, 29621

  • Study site

    Augusta, Georgia, 30904

  • Study site

    Baltimore, Maryland, 21229

  • Study site

    Beaver, Pennsylvania, 15009

  • Study site

    Birmingham, Alabama, 35233

  • Study site

    Brockton, Massachusetts, 02301

  • Study site

    Brooklyn Center, Minnesota, 55430

  • Study site

    Cadillac, Michigan, 49601

  • Study site

    Charlotte, North Carolina, 28211

  • Study site

    City of Saint Peters, Missouri, 63376

  • Study site

    Colorado Springs, Colorado, 80904

  • Study site

    Columbus, Ohio, 43213

  • Study site

    Conyers, Georgia, 30094

  • Study site

    Corvallis, Oregon, 97330

  • Study site

    Dallas, Texas, 75230

  • Study site

    Daytona Beach, Florida, 32117

  • Study site

    Delaware, Ohio, 43015

  • Study site

    Erie, Pennsylvania, 16508

  • Study site

    Eugene, Oregon, 97401

  • Study site

    Federal Way, Washington, 98003

  • Study site

    Fulton, New York, 13069

  • Study site

    Hampton, Virginia, 23666

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Honolulu, Hawaii, 96813

  • Study site

    Houston, Texas, 77030

  • Study site

    Hudson, New York, 12534

  • Study site

    Huntington Beach, California, 92646

  • Study site

    Huntsville, Alabama, 35802

  • Study site

    Indianapolis, Indiana, 46229

  • Study site

    Indianapolis, Indiana, 46254

  • Study site

    Jacksonville, Florida, 32205

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    La Jolla, California, 92037

  • Study site

    Lafayette, Indiana, 47905

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Los Angeles, California, 90017

  • Study site

    Manati, District of Columbia, 00674

  • Study site

    Marion, Ohio, 43302

  • Study site

    Miami, Florida, 33186

  • Study site

    Minneapolis, Minnesota, 55416

  • Study site

    New London, Connecticut, 06320

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    Panama City, Florida, 32401

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Reading, Pennsylvania, 17601

  • Study site

    Reading, Pennsylvania, 19606

  • Study site

    Richmond, Virginia, 23249

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Rochester, New York, 14609

  • Study site

    Roseville, California, 95661

  • Study site

    San Francisco, California, 94109

  • Study site

    Scottsdale, Arizona, 85254

  • Study site

    Shelby, North Carolina, 28150

  • Study site

    Shippensburg, Pennsylvania, 17257

  • Study site

    Snellville, Georgia, 30029

  • Study site

    South Bend, Indiana, 46628

  • Study site

    South Burlington, Vermont, 05403

  • Study site

    Statesville, North Carolina, 28625

  • Study site

    Tacoma, California, 98405

  • Study site

    Tallassee, Alabama, 36078

  • Study site

    Tampa, Florida, 33606

  • Study site

    Warminster, Pennsylvania, 18974

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany7 sites

  • Study site

    Berlin, 10115

  • Study site

    Dormagen, 41539

  • Study site

    Dresden, 01307

  • Study site

    Kiel Kronshagen, 24119

  • Study site

    München, 80336

  • Study site

    Sulzbach-Rosenberg, 92237

  • Study site

    Villingen-Schwenningen, 78048

Other trials in Germany

Mexico7 sites

  • Study site

    Cuernavaca, 62250

  • Study site

    Hermosillo, 83200

  • Study site

    Jalisco, 44690

  • Study site

    Mexico City, 06700

  • Study site

    Mexico City, 11520

  • Study site

    Monterrey, 64000

  • Study site

    Pachuca, 42086

Other trials in Mexico

Poland7 sites

  • Study site

    Bialystok, 15-445

  • Study site

    Gdansk, 80-858

  • Study site

    Kamieniec Ząbkowicki, 57-230

  • Study site

    Rzeszów, 35-073

  • Study site

    Skierniewice, 96-100

  • Study site

    Sobótka, 55-050

  • Study site

    Wroclaw, 51-124

Other trials in Poland

Canada5 sites

  • Study site

    London, Ontario, N6A 4V2

  • Study site

    Montreal, Quebec, H2W 1T8

  • Study site

    Pointe-Claire, Quebec, H9R 4S3

  • Study site

    Thornhill, Ontario, L4J 8L7

  • Study site

    Toronto, Ontario, M9W 4L6

Other trials in Canada

France5 sites

  • Study site

    Bondy, 93143

  • Study site

    Nantes, 44093

  • Study site

    Poitiers, 86021

  • Study site

    Rennes, 35203

  • Study site

    Saint-Mandé, 94163

Other trials in France

Romania5 sites

  • Study site

    Bucharest, 020359

  • Study site

    Buzău, 120203

  • Study site

    Cluj-Napoca, 400006

  • Study site

    Ploieşti, 100163

  • Study site

    Ploieşti, 100342

Other trials in Romania

Slovakia5 sites

  • Study site

    Levice, 93405

  • Study site

    Prešov, 080 01

  • Study site

    Šamorín, 931 01

  • Study site

    Trebišov, 07501

  • Study site

    Trenčín, 911 01

Other trials in Slovakia

South Korea5 sites

  • Study site

    Gyeonggi-do, 443-380

  • Study site

    Gyeonggi-do

  • Study site

    Seoul, 152-703

  • Study site

    Seoul

  • Study site

    Wŏnju, 220-701

Other trials in South Korea

United Kingdom5 sites

  • Study site

    Bexhill-on-Sea, TN39 4SP

  • Study site

    Crawley, RH10 7DX

  • Study site

    Glasgow, G46 8NY

  • Study site

    Hinckley, LE10 2SE

  • Study site

    Reading, RG7 3SQ

Other trials in United Kingdom

Norway4 sites

  • Study site

    Elverum, 2401

  • Study site

    Oslo, 0027

  • Study site

    Oslo, 0176

  • Study site

    Oslo, 0407

Other trials in Norway

Spain4 sites

  • Study site

    Almería, Almeria, 04001

  • Study site

    Bacarot Alicant, Alicante, 03114

  • Study site

    Seville, Sevilla, 41010

  • Study site

    Valencia, Valencia, 46014

Other trials in Spain

Taiwan4 sites

  • Study site

    Taichung, 407

  • Study site

    Taipei, 114

  • Study site

    Taipei, 220

  • Study site

    Taoyuan County, 333

Other trials in Taiwan

Argentina3 sites

  • Study site

    Buenos Aires, C1012

  • Study site

    Buenos Aires, C1213AAH

  • Study site

    Mar del Plata, B7600DHK

Other trials in Argentina

Sweden3 sites

  • Study site

    Ljungby, 34182

  • Study site

    Örebro, 701 85

  • Study site

    Stockholm, 14186

Other trials in Sweden

Switzerland3 sites

  • Study site

    Basel, 4031

  • Study site

    Geneva, 1211

  • Study site

    Zurich, 8063

Other trials in Switzerland

Australia2 sites

  • Study site

    Adelaide, South Australia, 5000

  • Study site

    Freemantle, Queensland, 6959

Other trials in Australia

Peru2 sites

  • Study site

    Lima, Lima 33

  • Study site

    Lima, Lima 9

Other trials in Peru

Puerto Rico2 sites

  • Study site

    Caguas, 00725

  • Study site

    Carolina, 00983

Other trials in Puerto Rico

South Africa2 sites

  • Study site

    Cape Town, 7130

  • Study site

    Pretoria, 0002

Other trials in South Africa

Thailand2 sites

  • Study site

    Bangkok, 10330

  • Study site

    Songkhla, 90112

Other trials in Thailand

Greece1 site

  • Study site

    Larissa, 41110

Other trials in Greece

Turkey (Türkiye)1 site

  • Study site

    Istanbul, 34390

Other trials in Turkey (Türkiye)

About this study

Official title: A Multicenter, Randomized, Double-dummy, Placebo and Active-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Sitagliptin and Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin.

This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.

Being tested
Metformin, Placebo (matching sitagliptin), Placebo (matching taspoglutide), Sitagliptin, 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.

  • MetforminDrug

    As prescribed

  • Placebo (matching sitagliptin)Drug

    Once daily oral administration of placebo (matching sitagliptin).

  • Placebo (matching taspoglutide)Drug

    Once weekly subcutaneous (sc) injection of placebo (matching taspoglutide).

  • SitagliptinDrug

    Once daily oral administration of 100 mg of sitagliptin.

  • TaspoglutideDrug

    Once weekly subcutaneous (sc) injection of 10 mg or 20 mg of taspoglutide.

Study groups in NCT00754988
Study groupRoleWhat they receive
PlaceboPlacebo comparatorOnce daily oral administration of placebo (matching sitagliptin). Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
Receives: Drug: Metformin; Drug: Placebo (matching sitagliptin); Drug: Placebo (matching taspoglutide)
SitagliptinActive comparatorOnce daily oral administration of 100 mg of sitagliptin. Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
Receives: Drug: Metformin; Drug: Placebo (matching taspoglutide); Drug: Sitagliptin
Taspoglutide 10 mgExperimentalOnce weekly subcutaneous (sc) injection of 10 mg of taspoglutide. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.
Receives: Drug: Metformin; Drug: Placebo (matching sitagliptin); Drug: Taspoglutide
Taspoglutide up-titrated to 20 mgExperimentalOnce weekly sc injection of 10 mg of taspoglutide for the first 4 weeks, then up-titrated to once weekly sc injection of 20 mg of taspoglutide from week 5 onwards. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.
Receives: Drug: Metformin; Drug: Placebo (matching sitagliptin); Drug: Taspoglutide

What is being measured

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

  1. Mean changes in HbA1c

    Measured: 24 weeks

Secondary outcomes (2)

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

    Measured: 24 weeks

  2. 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 startOct 2008
  3. Primary completionMar 2011
  4. Study completionMar 2011

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
Double blind
Who is masked
Participant, Investigator
Enrolment
666 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00754988
Sponsor's protocol ID
BC21713
Other IDs
2008-001854-42, 2008
Status last verified
Nov 2016
First submitted
17 Sep 2008
Last updated
4 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin, Sitagliptin and Taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 148 sites in 23 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 5 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 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 148 sites in United States, Germany, Mexico, Poland, Canada and 18 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. Some participants in this study may receive a placebo. 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?

Mean changes 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 NCT00754988.

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 4 Nov 2016.

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Clinical Trial NCT00754988 | AzTrials