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A Titration 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:
NCT00460941
First received: April 16, 2007
Last updated: May 23, 2013
Last verified: May 2013
History of Changes

April 16, 2007
May 23, 2013
April 2007
January 2008   (final data collection date for primary outcome measure)
Percentage of patients withdrawn because of gastrointestinal effects [ Time Frame: Week 9 ] [ Designated as safety issue: Yes ]
Percentage of patients withdrawn because of gastrointestinal adverse events.
Complete list of historical versions of study NCT00460941 on ClinicalTrials.gov Archive Site
Mean changes in 24h blood glucose AUC, FPG, fructosamine, HbAlc, body weight, AEs, laboratory parameters. [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
Efficacy: Mean changes in 24h blood glucose AUC, FPG, fructosamine, HbA1c, body weight. Safety: AEs, laboratory parameters.
Not Provided
Not Provided
 
A Titration Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.
A Double-blind, Placebo-controlled Titration Study to Investigate the Tolerability, Safety and Pharmacodynamic Profile of a GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

This 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses 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 (at a dose of 20mg, or a starting dose of 20mg escalating to either 30mg or 40mg), weekly. 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
    20mg sc weekly
  • Drug: taspoglutide
    20mg-30mg sc weekly
  • Drug: taspoglutide
    20mg-40mg sc weekly
  • Drug: Placebo
    sc weekly
  • Experimental: 1
    Intervention: Drug: taspoglutide
  • Experimental: 2
    Intervention: Drug: taspoglutide
  • Experimental: 3
    Intervention: Drug: taspoglutide
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Ratner R, Nauck M, Kapitza C, Asnaghi V, Boldrin M, Balena R. Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebo-controlled study. Diabet Med. 2010 May;27(5):556-62.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • male,and post-menopausal or surgically sterilized female, patients, 18-75 years of age;
  • type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
  • HbA1c >=7.0% and <=9.5% at screening;
  • stable weight +/-10% for >=3 months before screening.

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • clinically significant gastrointestinal disease;
  • 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;
  • previous exposure to GLP-1 or GLP-1 analogues.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   France,   Germany,   Mexico,   Peru,   Puerto Rico
 
NCT00460941
BC20728
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