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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:
ClinicalTrials.gov Identifier:
NCT00744926
First Posted: September 1, 2008
Last Update Posted: July 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
August 29, 2008
September 1, 2008
July 28, 2016
August 2008
April 2010   (Final data collection date for primary outcome measure)
Absolute change from baseline in HbA1c [ Time Frame: 24 weeks ]
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 ]
  • Change from baseline in fasting plasma glucose; change from baseline in body weight. [ Time Frame: 24 weeks ]
  • 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 ]
  • Change from baseline in fasting plasma glucose; change from baseline in body weight. [ Time Frame: 24 weeks ]
  • 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 ]
  • Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies. [ Time Frame: Throughout study ]
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 taspoglutide compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) or placebo. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: taspoglutide 10mg sc
    Intervention: Drug: taspoglutide
  • Experimental: taspoglutide 10mg/20mg sc
    Intervention: Drug: taspoglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
373
April 2010
April 2010   (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-glutamic acid decarboxylase (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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Guatemala,   Israel,   Mexico,   Peru,   Romania,   Russian Federation,   Slovakia,   Taiwan,   Ukraine,   United States
Brazil,   Bulgaria,   Serbia
 
NCT00744926
BC20750
2008-001765-28
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2016

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