A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00423501
First received: January 17, 2007
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharma codynamics of multiple doses and regimens of a GLP-1 analogue in patients with t ype 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analog ue, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. All patients will c ontinue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: taspoglutide
Drug: Placebo
Phase 2

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 Double Blind, Placebo-controlled, Dose-ranging Study to Investigate the Effect on Glycemic Control, Safety, Pharmacokinetics and Pharmacodynamics of GLP-1 in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Absolute change from baseline in HbAlc [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Changes in lipid profile [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, primary pharmacokinetic parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 306
Study Start Date: February 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: taspoglutide
5mg sc weekly
Experimental: 2 Drug: taspoglutide
10mg sc weekly
Experimental: 3 Drug: taspoglutide
20mg sc weekly
Placebo Comparator: 6 Drug: Placebo
sc weekly
Experimental: 4 Drug: taspoglutide
10mg sc every 2 weeks
Experimental: 5 Drug: taspoglutide
20mg sc every 2 weeks

  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, with stable metformin treatment for >=3 months;
  • stable weight +/-10% for >=3 months before screening.

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
  • use of weight-lowering medications in the last 3 months;
  • uncontrolled hypertension.
  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: NCT00423501

  Show 49 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00423501     History of Changes
Other Study ID Numbers: BC20688
Study First Received: January 17, 2007
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
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014