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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:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00423501
First received: January 17, 2007
Last updated: May 13, 2009
Last verified: May 2009
History of Changes
  Purpose

This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. All patients will continue 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: GLP-1
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:

U.S. FDA Resources

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 Completion Date: November 2007
Arms Assigned Interventions
Experimental: 1 Drug: GLP-1
5mg sc weekly
Experimental: 2 Drug: GLP-1
10mg sc weekly
Experimental: 3 Drug: GLP-1
20mg sc weekly
Experimental: 4 Drug: GLP-1
10mg sc every 2 weeks
Experimental: 5 Drug: GLP-1
20mg sc every 2 weeks
Placebo Comparator: 6 Drug: Placebo
sc 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, 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
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: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00423501     History of Changes
Other Study ID Numbers: BC20688
Study First Received: January 17, 2007
Last Updated: May 13, 2009
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
Glucagon-Like Peptide 1
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 19, 2013