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Diabetes Mellitus Type 2Phase 3NCT00744367

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

A Phase 3 study testing metformin, pioglitazone and taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 113 sites in 9 countries.

Completed

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

Official record
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Trial summary

This 3 arm study will assess the efficacy of taspoglutide on glycemic control (as assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone, compared to placebo after 24 weeks of treatment. 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, pioglitazone and taspoglutide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
326 participants
Where
113 sitesin 9 countries
Study dates
Oct 2008to Nov 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 age;
  • type 2 diabetes receiving pioglitazone (>= 30 mg/day) and metformin (>= 1500 mg/day) for at least 12 weeks prior to screening;
  • HbA1c >=7.0% and <=10.0% at screening;
  • BMI >= 25 (>23 for Asians) and <=45 kg/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

113 sites in 9 countries.

113 sites in 9 countries

United States76 sites

  • Study site

    Albany, New York, 12206-1098

  • Study site

    Athens, Ohio, 45701

  • Study site

    Aurora, Illinois, 60504

  • Study site

    Beaver, Pennsylvania, 15009

  • Study site

    Bellaire, Texas, 77401

  • Study site

    Bensalem, Pennsylvania, 19020

  • Study site

    Biloxi, Mississippi, 39531

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Bismarck, North Dakota, 58501

  • Study site

    Bradenton, Florida, 34208

  • Study site

    Brooklyn, New York, 11218

  • Study site

    Buena Park, California, 90620

  • Study site

    Carlisle, Pennsylvania, 17015

  • Study site

    Charlotte, North Carolina, 28262

  • Study site

    Charlotte, North Carolina, 28277

  • Study site

    Chiefland, Florida, 32626

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    City of Saint Peters, Missouri, 63376

  • Study site

    Cranston, Rhode Island, 02920

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dallas, Texas, 75231

  • Study site

    Des Moines, Iowa, 50314

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Federal Way, Washington, 98003

  • Study site

    Ferndale, Michigan, 48220

  • Study site

    Fort Myers, Florida, 33907

  • Study site

    Frederick, Maryland, 21702

  • Study site

    Gainesville, Florida, 32607

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Hamden, Connecticut, 06518

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Houston, Texas, 77030

  • Study site

    Hudson, New York, 12534

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Kalamazoo, Michigan, 49048

  • Study site

    Kettering, Ohio, 45429

  • Study site

    Lake Success, New York, 11042

  • Study site

    Lancaster, California, 93534

  • Study site

    Las Vegas, Nevada, 89148

  • Study site

    Levittown, Pennsylvania, 19056

  • Study site

    Lexington, Kentucky, 40504

  • Study site

    Libertyville, Illinois, 60048

  • Study site

    Loma Linda, California, 92354

  • Study site

    Madisonville, Kentucky, 42431

  • Study site

    Medford, Oregon, 97504

  • Study site

    Melrose Park, Pennsylvania, 19027

  • Study site

    Miami, Florida, 33136

  • Study site

    Mooresville, North Carolina, 28117

  • Study site

    Muscle Shoals, Alabama, 35661

  • Study site

    Nampa, Idaho, 83687

  • Study site

    New Orleans, Louisiana, 70121

  • Study site

    New Port Richey, Florida, 34652

  • Study site

    Norman, Oklahoma, 73071

  • Study site

    Ocala, Florida, 34474

  • Study site

    Olive Branch, Mississippi, 38654

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Oxon Hill, Maryland, 20745

  • Study site

    Phoenix, Arizona, 85028

  • Study site

    Phoenix, Arizona, 85032

  • Study site

    Pittsburgh, Pennsylvania, 15236

  • Study site

    Plantation, Florida, 33317

  • Study site

    Rancho Cucamonga, California, 91730

  • Study site

    Roseville, California, 95661

  • Study site

    Salt Lake City, Utah, 84102

  • Study site

    San Antonio, Texas, 78205

  • Study site

    San Diego, California, 92161

  • Study site

    Staten Island, New York, 10301

  • Study site

    Tampa, Florida, 33614

  • Study site

    Topeka, Kansas, 66614

  • Study site

    Walnut Creek, California, 94598

  • Study site

    Washington D.C., District of Columbia, 20017

  • Study site

    Wheat Ridge, Colorado, 80033

  • Study site

    Wilmington, North Carolina, 28401

Other trials in United States

Brazil13 sites

  • Study site

    Brasília, 70390-155

  • Study site

    Forlateza, 60430-350

  • Study site

    Fortaleza, 60120-021

  • Study site

    Fortaleza, 60155-290

  • Study site

    Fortaleza, 60430-370

  • Study site

    Mogi Das Cruzes - Sp, 08780-090

  • Study site

    Passo Fundo, 99010-901

  • Study site

    Porto Alegre, 90035-001

  • Study site

    Recife, 50100-130

  • Study site

    São Paulo, 01221-020

  • Study site

    São Paulo, 01244-030

  • Study site

    São Paulo, 04022-001

  • Study site

    São Paulo, 05403-000

Other trials in Brazil

Canada6 sites

  • Study site

    Hamilton, Ontario, L8N 3Z5

  • Study site

    London, Ontario, N6A 5R8

  • Study site

    Montreal, Quebec, H2W 1T8

  • Study site

    Mount Pearl, Newfoundland and Labrador, A1N 1W7

  • Study site

    Pointe-Claire, Quebec, H9R 4S3

  • Study site

    Toronto, Ontario, M9W 4L6

Other trials in Canada

Germany5 sites

  • Study site

    Falkensee, 14612

  • Study site

    Karlsruhe, 76199

  • Study site

    Mainz, 55116

  • Study site

    Neuwied, 56564

  • Study site

    Potsdam, 14469

Other trials in Germany

France4 sites

  • Study site

    Bondy, 93143

  • Study site

    Dijon, 21079

  • Study site

    Nantes, 44093

  • Study site

    Narbonne, 11108

Other trials in France

Mexico3 sites

  • Study site

    Chihuahua City, 31238

  • Study site

    Jalisco, 44690

  • Study site

    Mexico City, 11650

Other trials in Mexico

Puerto Rico3 sites

  • Study site

    Carolina, 00983

  • Study site

    Guyanabo, San Juan, 00920

  • Study site

    San Juan, 00926-2832

Other trials in Puerto Rico

Guatemala2 sites

  • Study site

    Guatemala City, 01010

  • Study site

    Guatemala City

Other trials in Guatemala

Costa Rica1 site

  • Study site

    San José, 755-1000

Other trials in Costa Rica

About this study

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

This 3 arm study will assess the efficacy of taspoglutide on glycemic control (as assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable metformin plus pioglitazone treatment. After the first 24 weeks 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 1-2 years, and the target sample size is 100-500 individuals.

Being tested
metformin, pioglitazone, placebo, 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

    >1500 mg/day or maximum tolerated dose (MTD)

  • pioglitazoneDrug

    >= 30 mg/day

  • placeboDrug

    sc once weekly

  • taspoglutideDrug

    10 mg sc once weekly;

  • taspoglutideDrug

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

Study groups in NCT00744367
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo in addition to continued stable metformin plus pioglitazone treatment. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly.
Receives: Drug: metformin; Drug: pioglitazone; Drug: placebo; Drug: taspoglutide
Taspoglutide 10mgExperimentalTaspoglutide 10mg once weekly in addition to continued stable metformin plus pioglitazone treatment
Receives: Drug: metformin; Drug: pioglitazone; Drug: taspoglutide
Taspoglutide 10mg/20mgExperimentalTaspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued stable metformin plus pioglitazone treatment.
Receives: Drug: metformin; Drug: pioglitazone; 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 (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; beta cell function.

    Measured: 24 weeks

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

    Measured: Throughout the study

Timeline

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

  1. First posted1 Sep 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionNov 2010
  4. Study completionNov 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
Double blind
Who is masked
Participant, Investigator
Enrolment
326 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00744367
Sponsor's protocol ID
BC20963
Other IDs
2008-001744-39, 2008
Status last verified
Aug 2016
First submitted
29 Aug 2008
Last updated
5 Aug 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing metformin, pioglitazone and taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 113 sites in 9 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 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in United States, Brazil, Canada, Germany, France and 4 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?

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 NCT00744367.

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 5 Aug 2016.

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