A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00823992
Recruitment Status : Completed
First Posted : January 16, 2009
Last Update Posted : July 28, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly) The anticipated time on study treatment is 12 months, and the target sample size is 100-500 individuals.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: placebo Drug: taspoglutide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Taspoglutide on Glycemic Control, and Its Safety and Tolerability, in Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy.
Study Start Date : January 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin

Arm Intervention/treatment
Placebo Comparator: placebo Drug: placebo
sc once weekly

Experimental: taspoglutide Drug: taspoglutide
10mg sc once weekly for 4 weeks, then 20mg sc once weekly

Primary Outcome Measures :
  1. Absolute change from baseline in HbA1c [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in body weight;% of patients achieving >=5% weight loss [ Time Frame: 24 weeks ]
  2. % of patients achieving target HbA1c <=6.5%, <=7.0%; change from baseline in fasting plasma glucose; change from baseline in lipid profile; relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function [ Time Frame: 24 weeks ]
  3. Safety:Adverse events,clinical laboratory tests, vital signs,physical examination, ECG, anti-taspoglutide antibodies\n [ Time Frame: At planned clinic visits, for 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes mellitus, receiving metformin at a stable dose of >=1500mg/day for at least 12 weeks;
  • HbA1c >=6.5% and <=9.5% at screening;
  • BMI >=30 and <=50 kg/m2 at screening;
  • stable weight +/-5% for at least 12 weeks prior to screening.

Exclusion Criteria:

  • history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months;
  • evidence of clinically significant diabetic complications;
  • myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00823992

  Hide Study Locations
United States, California
Bermuda Dunes, California, United States, 92203
Lajolla, California, United States, 92037
Los Angeles, California, United States, 90057
Mission Viejo, California, United States, 92691
United States, Florida
Brooksville, Florida, United States, 34601
Miami, Florida, United States, 33133
St. Petersburg, Florida, United States, 33709
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Illinois
Chicago, Illinois, United States, 60607
United States, Indiana
Avon, Indiana, United States, 46123
United States, Louisiana
New Orleans, Louisiana, United States, 70121
United States, Maine
Bangor, Maine, United States, 04401
United States, Michigan
Royal Oak, Michigan, United States, 48073
United States, Mississippi
Picayune, Mississippi, United States, 39466
United States, New Jersey
Clifton, New Jersey, United States, 07012
Toms River, New Jersey, United States, 08753
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
New York, New York, United States, 10025
Springfield Gardens, New York, United States, 11413
United States, North Carolina
Charlotte, North Carolina, United States, 28277
Shelby, North Carolina, United States, 28150
United States, Oklahoma
Norman, Oklahoma, United States, 73069
United States, Oregon
Medford, Oregon, United States, 97504
United States, South Carolina
Clinton, South Carolina, United States, 29325
United States, Tennessee
Kingsport, Tennessee, United States, 37660
United States, Texas
Dallas, Texas, United States, 75246
Houston, Texas, United States, 77074
Midland, Texas, United States, 79707
San Antonio, Texas, United States, 78237
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1L8
Canada, Nova Scotia
Sherbrooke, Nova Scotia, Canada, J1G 2E8
Canada, Ontario
Etobicoke, Ontario, Canada, M9R 4E1
Hamilton, Ontario, Canada, L8N 3Z5
Oakville, Ontario, Canada, L6H 3P1
Toronto, Ontario, Canada, M9W 4L6
Aschaffenburg, Germany, 63739
Berlin, Germany, 10115
Bochum, Germany, 44791
Dortmund, Germany, 44137
Dresden, Germany, 01307
Falkensee, Germany, 14612
Mainz, Germany, 55116
Münster, Germany, 48145
Neuwied, Germany, 56564
Ancona, Italy, 60131
Ravenna, Italy, 48100
Roma, Italy, 00161
Siena, Italy, 53100
Macedonia, The Former Yugoslav Republic of
Bitola, Macedonia, The Former Yugoslav Republic of, 7000
Gniewkowo, Poland, 88-140
Kamieniec Zabkowicki, Poland, 57-230
Lublin, Poland, 20-044
Puerto Rico
Carolina, Puerto Rico, 00983
Rio Grande, Puerto Rico, 00745
Rio Piedras, Puerto Rico, 00921
Russian Federation
Kemerovo, Russian Federation, 650002
Moscow, Russian Federation, 105229
Moscow, Russian Federation, 115280
Moscow, Russian Federation, 117036
Ryazan, Russian Federation, 390026
Saratov, Russian Federation, 410002
Smolensk, Russian Federation, 214019
Tumen, Russian Federation, 625023
Barcelona, Spain, 08036
Lerida, Spain, 25198
Oviedo, Spain, 33006
United Kingdom
Bath, United Kingdom, BA2 4BY
Birmingham, United Kingdom, B9 5SS
Glasgow, United Kingdom, G45 9AW
Midsomer Norton, United Kingdom, BA3 2UH
Rotherham, United Kingdom, S65 1DA
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00823992     History of Changes
Other Study ID Numbers: BC22092
First Posted: January 16, 2009    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016

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