A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00744367
First received: August 29, 2008
Last updated: October 6, 2014
Last verified: October 2014

August 29, 2008
October 6, 2014
October 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 NCT00744367 on ClinicalTrials.gov Archive Site
  • Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); responder rates for body weight; beta cell function. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Safety: adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies. [ Time Frame: Throughout the study ] [ 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 Metformin Plus Pioglitazone.
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone

This 3 arm study will assess the efficacy of taspoglutide on glycemic control (a s assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately cont rolled with metformin plus pioglitazone, compared to placebo after 24 weeks of t reatment. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable metformin p lus pioglitazone treatment. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (aft er 4 weeks of taspoglutide 10mg once weekly. The anticipated time on study treat ment is 1-2 years, and the target sample size is 100-500 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: metformin
    >1500 mg/day or MTD
  • Drug: pioglitazone
    >= 30 mg/day
  • Drug: placebo
    sc once weekly
  • Drug: taspoglutide
    10 mg sc once weekly;
  • Drug: taspoglutide
    20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly)
  • Experimental: 1
    Interventions:
    • Drug: metformin
    • Drug: pioglitazone
    • Drug: taspoglutide
  • Experimental: 2
    Interventions:
    • Drug: metformin
    • Drug: pioglitazone
    • Drug: taspoglutide
  • Placebo Comparator: 3
    Interventions:
    • Drug: metformin
    • Drug: pioglitazone
    • 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
326
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 18-75 years age;
  • type 2 diabetes receiving pioglitazone (>= 30 mg/day) and metformin (>= 1500 mg/day) for at least 12 weeks prior to screening;
  • HbA1c >=7.0% and <=10.0% at screening;
  • BMI >= 25 (>23 for Asians) and <=45 kg/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;
  • clinically symptomatic gastrointestinal disease;
  • 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 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico,   Brazil,   Canada,   Costa Rica,   France,   Germany,   Guatemala,   Mexico
 
NCT00744367
BC20963, 2008-001744-39
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