A Study of Taspoglutide in Type 2 Diabetic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00811460
First received: December 18, 2008
Last updated: August 4, 2014
Last verified: August 2014

December 18, 2008
August 4, 2014
November 2008
August 2009   (final data collection date for primary outcome measure)
Incremental area under insulin concentration time curve relative to basal insulin concentration [ Time Frame: First 10 minutes after glucose bolus ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00811460 on ClinicalTrials.gov Archive Site
  • Incremental area under insulin concentration time curve relative to basal insulin concentration [ Time Frame: 10-120 minutes after glucose bolus ] [ Designated as safety issue: No ]
  • Adverse events, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Taspoglutide in Type 2 Diabetic Patients
A Double-blind, Crossover, Randomized, Placebo-controlled Study to Investigate the Effect of Two Different Doses of Taspoglutide IRF Administered as Continuous Subcutaneous Infusion on First- and Second-phase Insulin Secretion in Type 2 Diabetic Patients

This crossover study will assess the effect of 2 doses of Taspoglutide on first- and second-phase insulin secretion in patients with type 2 diabetes. Patients w ill receive a continuous subcutaneous infusion of a)the Immediate Release Formul ation (IRF)of Taspoglutide 300 micrograms/day for 2 days followed by Taspoglutid e 800 micrograms/day for 2 days or b)saline placebo for 2+2 days. After a washou t period of 10-15 days, patients will be crossed-over for further treatment;thos e receiving Taspoglutide in period 1 will receive placebo in period 2, and vice versa. On days 2 and 4 of each period, insulin secretion patterns will be assess ed. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: taspoglutide
    300micrograms/day sc for 2 days
  • Drug: taspoglutide
    800 micrograms/day sc for 2 days
  • Drug: Placebo
    sc for 4 days
Experimental: 1
Interventions:
  • Drug: taspoglutide
  • Drug: taspoglutide
  • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 18-65 years of age;
  • type 2 diabetes mellitus;
  • treated with diet and exercise alone, or in combination with stable metformin for at least 3 months prior to screening.

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • type 2 diabetes duration of <3 months;
  • treatment with any oral anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
  • treatment with insulin for >7 days within 6 months prior to screening.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00811460
BP21844, 2008-003582-97
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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