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

NCT00744367 | Completed Phase 3

• 2 other identifiers: BC209632008-001744-39
• Study Type: interventional
• Target: 326
• Locations: 9 countries
• Sites: 113

Brief 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. 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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline in HbA1c

  24 weeks

Secondary Outcomes (2)

• 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.

  24 weeks

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

  Throughout the study

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo 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.

Drug: metformin; Drug: pioglitazone; Drug: placebo; Drug: taspoglutide

Taspoglutide 10mg

EXPERIMENTAL

Taspoglutide 10mg once weekly in addition to continued stable metformin plus pioglitazone treatment

Drug: metformin; Drug: pioglitazone; Drug: taspoglutide

Taspoglutide 10mg/20mg

EXPERIMENTAL

Taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued stable metformin plus pioglitazone treatment.

Drug: metformin; Drug: pioglitazone; Drug: taspoglutide

Interventions

metformin DRUG

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

Placebo; Taspoglutide 10mg; Taspoglutide 10mg/20mg

pioglitazone DRUG

\>= 30 mg/day

Placebo; Taspoglutide 10mg; Taspoglutide 10mg/20mg

placebo DRUG

sc once weekly

Placebo

taspoglutide DRUG

10 mg sc once weekly;

Placebo; Taspoglutide 10mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (113)

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Birmingham, Alabama, 35209, United States

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Birmingham, Alabama, 35294, United States

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Huntsville, Alabama, 35801, United States

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Muscle Shoals, Alabama, 35661, United States

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Phoenix, Arizona, 85028, United States

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Phoenix, Arizona, 85032, United States

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Buena Park, California, 90620, United States

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Lancaster, California, 93534, United States

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Loma Linda, California, 92354, United States

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Rancho Cucamonga, California, 91730, United States

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Roseville, California, 95661, United States

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San Diego, California, 92161, United States

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Walnut Creek, California, 94598, United States

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Wheat Ridge, Colorado, 80033, United States

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Hamden, Connecticut, 06518, United States

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Washington D.C., District of Columbia, 20017, United States

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Bradenton, Florida, 34208, United States

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Chiefland, Florida, 32626, United States

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Fort Myers, Florida, 33907, United States

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Gainesville, Florida, 32607, United States

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Hollywood, Florida, 33021, United States

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Miami, Florida, 33136, United States

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New Port Richey, Florida, 34652, United States

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Ocala, Florida, 34474, United States

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Plantation, Florida, 33317, United States

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Tampa, Florida, 33614, United States

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Nampa, Idaho, 83687, United States

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Aurora, Illinois, 60504, United States

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Libertyville, Illinois, 60048, United States

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Evansville, Indiana, 47714, United States

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Des Moines, Iowa, 50314, United States

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Topeka, Kansas, 66614, United States

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Lexington, Kentucky, 40504, United States

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Madisonville, Kentucky, 42431, United States

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New Orleans, Louisiana, 70121, United States

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Frederick, Maryland, 21702, United States

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Oxon Hill, Maryland, 20745, United States

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Detroit, Michigan, 48202, United States

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Ferndale, Michigan, 48220, United States

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Kalamazoo, Michigan, 49048, United States

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Biloxi, Mississippi, 39531, United States

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Olive Branch, Mississippi, 38654, United States

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City of Saint Peters, Missouri, 63376, United States

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Omaha, Nebraska, 68114, United States

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Omaha, Nebraska, 68131, United States

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Las Vegas, Nevada, 89148, United States

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Albany, New York, 12206-1098, United States

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Brooklyn, New York, 11218, United States

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Hudson, New York, 12534, United States

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Lake Success, New York, 11042, United States

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Staten Island, New York, 10301, United States

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Charlotte, North Carolina, 28262, United States

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Charlotte, North Carolina, 28277, United States

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Mooresville, North Carolina, 28117, United States

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Wilmington, North Carolina, 28401, United States

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Bismarck, North Dakota, 58501, United States

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Athens, Ohio, 45701, United States

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Cincinnati, Ohio, 45219, United States

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Kettering, Ohio, 45429, United States

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Norman, Oklahoma, 73071, United States

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Medford, Oregon, 97504, United States

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Beaver, Pennsylvania, 15009, United States

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Bensalem, Pennsylvania, 19020, United States

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Carlisle, Pennsylvania, 17015, United States

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Levittown, Pennsylvania, 19056, United States

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Melrose Park, Pennsylvania, 19027, United States

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Pittsburgh, Pennsylvania, 15236, United States

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Cranston, Rhode Island, 02920, United States

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Greer, South Carolina, 29651, United States

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Bellaire, Texas, 77401, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78205, United States

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Salt Lake City, Utah, 84102, United States

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Federal Way, Washington, 98003, United States

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Brasília, 70390-155, Brazil

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Forlateza, 60430-350, Brazil

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Fortaleza, 60120-021, Brazil

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Fortaleza, 60155-290, Brazil

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Fortaleza, 60430-370, Brazil

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Mogi Das Cruzes - Sp, 08780-090, Brazil

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Passo Fundo, 99010-901, Brazil

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Porto Alegre, 90035-001, Brazil

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Recife, 50100-130, Brazil

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São Paulo, 01221-020, Brazil

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São Paulo, 01244-030, Brazil

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São Paulo, 04022-001, Brazil

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São Paulo, 05403-000, Brazil

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Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada

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Hamilton, Ontario, L8N 3Z5, Canada

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London, Ontario, N6A 5R8, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Montreal, Quebec, H2W 1T8, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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San José, 755-1000, Costa Rica

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Bondy, 93143, France

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Dijon, 21079, France

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Nantes, 44093, France

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Narbonne, 11108, France

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Falkensee, 14612, Germany

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Karlsruhe, 76199, Germany

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Mainz, 55116, Germany

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Neuwied, 56564, Germany

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Potsdam, 14469, Germany

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Guatemala City, 01010, Guatemala

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Guatemala City, Guatemala

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Chihuahua City, 31238, Mexico

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Jalisco, 44690, Mexico

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Mexico City, 11650, Mexico

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Carolina, 00983, Puerto Rico

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Guyanabo, San Juan, 00920, Puerto Rico

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San Juan, 00926-2832, Puerto Rico

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; Pioglitazone; taspoglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 5, 2016

Record last verified: 2016-08

Locations

DE (5); ME (3); CO (1); US (76); CA (6); BR (13); GU (2); FR (4); PR (3)