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: July 7, 2014
Last verified: July 2014

July 16, 2008
July 7, 2014
July 2008
March 2011   (final data collection date for primary outcome measure)
Change in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00717457 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: taspoglutide
    10mg once weekly
  • Drug: taspoglutide
    10mg once weekly for 4 weeks followed by 20mg once weekly
  • Drug: exenatide
    5mg twice daily for 4 weeks followed by 10mg twice daily
  • Experimental: 1
    Intervention: Drug: taspoglutide
  • Experimental: 2
    Intervention: Drug: taspoglutide
  • Active Comparator: 3
    Intervention: Drug: exenatide
Rosenstock J, Balas B, Charbonnel B, Bolli GB, Boldrin M, Ratner R, Balena R; T-emerge 2 Study Group. The fate of taspoglutide, a weekly GLP-1 receptor agonist, versus twice-daily exenatide for type 2 diabetes: the T-emerge 2 trial. Diabetes Care. 2013 Mar;36(3):498-504. doi: 10.2337/dc12-0709. Epub 2012 Nov 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1189
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Canada,   Denmark,   Finland,   France,   Germany,   Greece,   Guatemala,   Israel,   Italy,   Korea, Republic of,   Mexico,   New Zealand,   Peru,   Puerto Rico,   Russian Federation,   South Africa,   Spain,   Sweden,   Switzerland,   Thailand,   Ukraine,   United Kingdom
 
NCT00717457
BC21625, 2008-001856-36
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP