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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00717457
First received: July 16, 2008
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This 3-arm study will assess the efficacy, safety and tolerability of taspogluti de compared with exenatide in patients with type 2 diabetes mellitus inadequatel y controlled with metformin, thiazolidinedione or a combination of both. Patient s will be randomized to receive taspoglutide (10mg once weekly or 10mg once week ly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice da ily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in ad dition 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: taspoglutide
Drug: exenatide
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
Experimental: 1 Drug: taspoglutide
10mg once weekly
Experimental: 2 Drug: taspoglutide
10mg once weekly for 4 weeks followed by 20mg once weekly
Active Comparator: 3 Drug: exenatide
5mg twice daily for 4 weeks followed by 10mg twice daily

  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 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 ClinicalTrials.gov identifier: NCT00717457

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

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00717457     History of Changes
Other Study ID Numbers: BC21625, 2008-001856-36
Study First Received: July 16, 2008
Last Updated: August 4, 2014
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
Exenatide
2,4-thiazolidinedione
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 20, 2014