A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00744926
First received: August 29, 2008
Last updated: October 6, 2014
Last verified: October 2014

August 29, 2008
October 6, 2014
August 2008
March 2011   (final data collection date for primary outcome measure)
Absolute change from baseline in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00744926 on ClinicalTrials.gov Archive Site
  • Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose; change from baseline in body weight. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Responder rates for HbA1c (target <=7.0%, <=6.5%); relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide Compared to Placebo, in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

This 3 arm study will assess the efficacy, safety and tolerability of taspogluti de compared to placebo in patients with type 2 diabetes mellitus inadequately co ntrolled with diet and exercise. Patients will be randomized to one of 3 treatme nt arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (aft er 4 weeks of taspoglutide 10mg sc once weekly) or placebo. After the first 24 w eeks patients on placebo will be switched to taspoglutide 10mg once weekly or ta spoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). Th e anticipated time on study treatment is 1 year, and the target sample size is 1 00-500 individuals.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: placebo
    sc, once weekly
  • Drug: taspoglutide
    10mg sc, once weekly
  • Drug: taspoglutide
    20mg sc, once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)
  • Experimental: 1
    Intervention: Drug: taspoglutide
  • Experimental: 2
    Intervention: Drug: taspoglutide
  • Placebo Comparator: 3
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
373
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 18-80 years of age;
  • drug naive patients with type 2 diabetes uncontrolled with diet and exercise;
  • tested negative for anti-GAD antibodies;
  • C-peptide (fasting) >=1.0ng/mL
  • HbA1c >=6.5% and <=10.0% at screening;
  • BMI >=25 (>23 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 mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
  • evidence of clinically significant diabetic complications;
  • symptomatic poorly controlled diabetes;
  • myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
  • known hemoglobinopathy or chronic anemia.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Guatemala,   Israel,   Mexico,   Peru,   Romania,   Russian Federation,   Slovakia,   Taiwan,   Ukraine
 
NCT00744926
BC20750, 2008-001765-28
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

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