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A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 16, 2008
Last updated: October 3, 2016
Last verified: October 2016
This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is >500 individuals.

Condition Intervention Phase
Diabetes Mellitus Type 2
Drug: exenatide
Drug: taspoglutide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients reaching target HbA1c <=7.0%, <=6.5% [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Beta cell function (proinsulin/insulin ratio) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 1189
Study Start Date: July 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: exenatide Drug: exenatide
5mg twice daily for 4 weeks followed by 10mg twice daily
Experimental: taspoglutide 10mg Drug: taspoglutide
10mg once weekly
Experimental: taspoglutide 10mg/20mg Drug: taspoglutide
10mg once weekly for 4 weeks followed by 20mg once weekly


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;
  • HbA1c >=7.0% and <=10% at screening;
  • BMI >=25kg/m2 (>23kg/m2 for Asians) and <=45kg/m2 at screening;
  • stable weight +/- 5% for at least 12 weeks prior to screening.

Exclusion Criteria:

  • history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes;
  • history of acute metabolic diabetic complications within the previous 6 months;
  • evidence of clinically significant diabetic complications;
  • known proliferative diabetic retinopathy;
  • myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;
  • any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator;
  • known hemoglobinopathy or chronic anemia;
  • clinically significant gastrointestinal disease.
  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 identifier: NCT00717457

  Show 216 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00717457     History of Changes
Other Study ID Numbers: BC21625  2008-001856-36 
Study First Received: July 16, 2008
Last Updated: October 3, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on October 27, 2016