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. - Full Text View

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 Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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)

Show 240 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BC21625, 2008-001856-36
Study First Received:	July 16, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00717457
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Exenatide
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

2,4-thiazolidinedione
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009