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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 is currently recruiting participants.
Verified by Hoffmann-La Roche, February 2009
First Received: July 16, 2008   Last Updated: February 17, 2009   History of Changes
Sponsored by: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00717457
  Purpose

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 3-12 months, and the target sample size is >500 individuals.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: taspoglutide
Drug: exenatide
 Phase III

MedlinePlus related topics: Diabetes
Drug Information available for: Exenatide Metformin
U.S. FDA Resources
Study Type: Interventional
Study Design: Open Label, Parallel Assignment, Randomized, Safety/Efficacy Study, 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

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 ]

Estimated Enrollment: 990
Study Start Date: July 2008
Estimated Study Completion Date: June 2010
Arms Assigned Interventions
1: Experimental Drug: taspoglutide
10mg once weekly
2: Experimental Drug: taspoglutide
10mg once weekly for 4 weeks followed by 20mg once weekly
3: Active Comparator 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717457

Contacts
Contact: Please reference Study ID Number: BC21625 973-235-5000
Contact: or 800-526-6367 (FOR US ONLY)

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United States, Alabama
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MOTHERWELL, United Kingdom, ML1 3JX
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche, +1 973 235 5000
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers: BC21625, 2008-001856-36
Study First Received: July 16, 2008
Last Updated: February 17, 2009
ClinicalTrials.gov Identifier: NCT00717457     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Hypoglycemic Agents
Metabolic Diseases
Exenatide
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
 2,4-thiazolidinedione
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Hypoglycemic Agents
Metabolic Diseases
Exenatide
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
 2,4-thiazolidinedione
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 16, 2009



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