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: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: taspoglutide
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Absolute change from baseline in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 373
Study Start Date: August 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: taspoglutide
10mg sc, once weekly
Experimental: 2 Drug: taspoglutide
20mg sc, once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)
Placebo Comparator: 3 Drug: placebo
sc, once weekly

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744926

  Show 58 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00744926     History of Changes
Other Study ID Numbers: BC20750, 2008-001765-28
Study First Received: August 29, 2008
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2014