A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00823992
First received: January 15, 2009
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This 2 arm study will assess the efficacy, safety and tolerability of taspogluti de compared to placebo in obese patients with type 2 diabetes mellitus inadequat ely controlled with metformin monotherapy. Patients will be randomized to receiv e taspoglutide (10mg sc once weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their prescribed, pre-existing metformin therapy.Aft er the first 24 weeks, patients on placebo will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly) The anticipated ti me on study treatment is 12 months, and the target sample size is 100-500 indivi duals.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: placebo
Drug: taspoglutide
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 Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Taspoglutide on Glycemic Control, and Its Safety and Tolerability, in Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy.

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:
  • Change from baseline in body weight;% of patients achieving >=5% weight loss [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • % of patients achieving target HbA1c <=6.5%, <=7.0%; change from baseline in fasting plasma glucose; change from baseline in lipid profile; 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 ]
  • Safety:Adverse events,clinical laboratory tests, vital signs,physical examination, ECG, anti-taspoglutide antibodies\n [ Time Frame: At planned clinic visits, for 12 months ] [ Designated as safety issue: No ]

Enrollment: 305
Study Start Date: January 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: taspoglutide
10mg sc once weekly for 4 weeks, then 20mg sc once weekly
Placebo Comparator: 2 Drug: placebo
sc once weekly

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes mellitus, receiving metformin at a stable dose of >=1500mg/day for at least 12 weeks;
  • HbA1c >=6.5% and <=9.5% at screening;
  • BMI >=30 and <=50 kg/m2 at screening;
  • stable weight +/-5% for at least 12 weeks prior to screening.

Exclusion Criteria:

  • history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months;
  • evidence of clinically significant diabetic complications;
  • myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.
  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: NCT00823992

  Show 71 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: NCT00823992     History of Changes
Other Study ID Numbers: BC22092, 2008-005809-20
Study First Received: January 15, 2009
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 22, 2014