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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 (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00423501
First received: January 17, 2007
Last updated: May 23, 2013
Last verified: May 2013
History of Changes

January 17, 2007
May 23, 2013
February 2007
November 2007   (final data collection date for primary outcome measure)
Absolute change from baseline in HbAlc [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Absolute change from baseline in HbA1c at the end of treatment.
Complete list of historical versions of study NCT00423501 on ClinicalTrials.gov Archive Site
  • 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 ]
Efficacy: absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon; changes in lipid profile. Safety: AEs, laboratory parameters. Pharmacokinetics: primary PK parameters.
Not Provided
Not Provided
 
A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.
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.

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: taspoglutide
    5mg sc weekly
  • Drug: taspoglutide
    10mg sc weekly
  • Drug: taspoglutide
    20mg sc weekly
  • Drug: taspoglutide
    10mg sc every 2 weeks
  • Drug: taspoglutide
    20mg sc every 2 weeks
  • Drug: Placebo
    sc weekly
  • Experimental: 1
    Intervention: Drug: taspoglutide
  • Experimental: 2
    Intervention: Drug: taspoglutide
  • Experimental: 3
    Intervention: Drug: taspoglutide
  • Experimental: 4
    Intervention: Drug: taspoglutide
  • Experimental: 5
    Intervention: Drug: taspoglutide
  • Placebo Comparator: 6
    Intervention: Drug: Placebo
Nauck MA, Ratner RE, Kapitza C, Berria R, Boldrin M, Balena R. Treatment with the human once-weekly glucagon-like peptide-1 analog taspoglutide in combination with metformin improves glycemic control and lowers body weight in patients with type 2 diabetes inadequately controlled with metformin alone: a double-blind placebo-controlled study. Diabetes Care. 2009 Jul;32(7):1237-43. Epub 2009 Apr 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
November 2007
November 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Bulgaria,   Germany,   Guatemala,   Hong Kong,   Latvia,   Lithuania,   Mexico,   Romania
 
NCT00423501
BC20688
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

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