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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00744367
First received: August 29, 2008
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This 3 arm study will assess the efficacy of taspoglutide on glycemic control (a s assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately cont rolled with metformin plus pioglitazone, compared to placebo after 24 weeks of t reatment. 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 p lus pioglitazone treatment. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (aft er 4 weeks of taspoglutide 10mg once weekly. The anticipated time on study treat ment is 1-2 years, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: metformin
Drug: pioglitazone
Drug: placebo
Drug: taspoglutide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Absolute change from baseline in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Safety: adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment: 326
Study Start Date: October 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: metformin
>1500 mg/day or MTD
Drug: pioglitazone
>= 30 mg/day
Drug: taspoglutide
10 mg sc once weekly;
Experimental: 2 Drug: metformin
>1500 mg/day or MTD
Drug: pioglitazone
>= 30 mg/day
Drug: taspoglutide
20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly)
Placebo Comparator: 3 Drug: metformin
>1500 mg/day or MTD
Drug: pioglitazone
>= 30 mg/day
Drug: placebo
sc once weekly

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744367

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
Birmingham, Alabama, United States, 35209
Huntsville, Alabama, United States, 35801
Muscle Shoals, Alabama, United States, 35661
United States, Arizona
Phoenix, Arizona, United States, 85032
Phoenix, Arizona, United States, 85028
United States, California
Buena Park, California, United States, 90620
Lancaster, California, United States, 93534
Loma Linda, California, United States, 92354
Rancho Cucamonga, California, United States, 91730
Roseville, California, United States, 95661
San Diego, California, United States, 92161
Walnut Creek, California, United States, 94598
United States, Colorado
Wheatridge, Colorado, United States, 80033
United States, Connecticut
Hamden, Connecticut, United States, 06518
United States, District of Columbia
Washington, District of Columbia, United States, 20017
United States, Florida
Bradenton, Florida, United States, 34208
Chiefland, Florida, United States, 32626
Fort Myers, Florida, United States, 33907
Gainesville, Florida, United States, 32607
Hollywood, Florida, United States, 33021
Miami, Florida, United States, 33136
New Port Richey, Florida, United States, 34652
Ocala, Florida, United States, 34474
Plantation, Florida, United States, 33317
Tampa, Florida, United States, 33614
United States, Idaho
Nampa, Idaho, United States, 83687
United States, Illinois
Aurora, Illinois, United States, 60504
Libertyville, Illinois, United States, 60048
United States, Indiana
Evansville, Indiana, United States, 47714
United States, Iowa
Des Moines, Iowa, United States, 50314
United States, Kansas
Topeka, Kansas, United States, 66614
United States, Kentucky
Lexington, Kentucky, United States, 40504
Madisonville, Kentucky, United States, 42431
United States, Louisiana
New Orleans, Louisiana, United States, 70121
United States, Maryland
Frederick, Maryland, United States, 21702
Oxon Hill, Maryland, United States, 20745
United States, Michigan
Detroit, Michigan, United States, 48202
Ferndale, Michigan, United States, 48220
Kalamazoo, Michigan, United States, 49048
United States, Mississippi
Biloxi, Mississippi, United States, 39531
Olive Branch, Mississippi, United States, 38654
United States, Missouri
St Peters, Missouri, United States, 63376
United States, Nebraska
Omaha, Nebraska, United States, 68131
Omaha, Nebraska, United States, 68114
United States, Nevada
Las Vegas, Nevada, United States, 89148
United States, New York
Albany, New York, United States, 12206-1098
Brooklyn, New York, United States, 11218
Hudson, New York, United States, 12534
Lake Success, New York, United States, 11042
Staten Island, New York, United States, 10301
United States, North Carolina
Charlotte, North Carolina, United States, 28277
Charlotte, North Carolina, United States, 28262
Mooresville, North Carolina, United States, 28117
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Bismarck, North Dakota, United States, 58501
United States, Ohio
Athens, Ohio, United States, 45701
Cincinnati, Ohio, United States, 45219
Kettering, Ohio, United States, 45429
United States, Oklahoma
Norman, Oklahoma, United States, 73071
United States, Oregon
Medford, Oregon, United States, 97504
United States, Pennsylvania
Beaver, Pennsylvania, United States, 15009
Bensalem, Pennsylvania, United States, 19020
Carlisle, Pennsylvania, United States, 17015
Levittown, Pennsylvania, United States, 19056
Melrose Park, Pennsylvania, United States, 19027
Pittsburgh, Pennsylvania, United States, 15236
United States, Rhode Island
Cranston, Rhode Island, United States, 02920
United States, South Carolina
Greer, South Carolina, United States, 29651
United States, Texas
Bellaire, Texas, United States, 77401
Dallas, Texas, United States, 75230
Dallas, Texas, United States, 75231
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78205
United States, Utah
Salt Lake City, Utah, United States, 84102
United States, Washington
Federal Way, Washington, United States, 98003
Brazil
Brasilia, Brazil, 70390-155
Forlateza, Brazil, 60430-350
Fortaleza, Brazil, 60430-370
Fortaleza, Brazil, 60155-290
Fortaleza, Brazil, 60120-021
Mogi Das Cruzes - Sp, Brazil, 08780-090
Passo Fundo, Brazil, 99010-901
Porto Alegre, Brazil, 90035-001
Recife, Brazil, 50100-130
Sao Paulo, Brazil, 04022-001
Sao Paulo, Brazil, 01244-030
Sao Paulo, Brazil, 05403-000
Sao Paulo, Brazil, 01221-020
Canada, Newfoundland and Labrador
Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
Canada, Ontario
Hamilton, Ontario, Canada, L8N 3Z5
London, Ontario, Canada, N6A 5R8
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
Montreal, Quebec, Canada, H2W 1T8
Pointe-claire, Quebec, Canada, H9R 4S3
Costa Rica
San Jose, Costa Rica, 755-1000
France
Bondy, France, 93143
Dijon, France, 21079
Nantes, France, 44093
Narbonne, France, 11108
Germany
Falkensee, Germany, 14612
Karlsruhe, Germany, 76199
Mainz, Germany, 55116
Neuwied, Germany, 56564
Potsdam, Germany, 14469
Guatemala
Guatemala, Guatemala, 01010
Guatemala, Guatemala
Mexico
Chihuahua, Mexico, 31238
Jalisco, Mexico, 44690
Mexico City, Mexico, 11650
Puerto Rico
Carolina, Puerto Rico, 00983
Guyanabo, San Juan, Puerto Rico, 00920
San Juan, Puerto Rico, 00926-2832
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00744367     History of Changes
Other Study ID Numbers: BC20963, 2008-001744-39
Study First Received: August 29, 2008
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014