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A Study of Taspoglutide in Type 2 Diabetic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00811460
First Posted: December 19, 2008
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
December 18, 2008
December 19, 2008
November 2, 2016
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 ]
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 ]
  • Adverse events, laboratory parameters [ Time Frame: Throughout study ]
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 will receive a continuous subcutaneous infusion of a)the Immediate Release Formulation (IRF)of Taspoglutide 300 micrograms/day for 2 days followed by Taspoglutide 800 micrograms/day for 2 days or b)saline placebo for 2+2 days. After a washout period of 10-15 days, patients will be crossed-over for further treatment;those 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 assessed. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus Type 2
  • Drug: Placebo
    sc for 4 days
  • Drug: taspoglutide
    300micrograms/day sc for 2 days
  • Drug: taspoglutide
    800 micrograms/day sc for 2 days
Experimental: 1
Interventions:
  • Drug: Placebo
  • Drug: taspoglutide
  • Drug: taspoglutide
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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00811460
BP21844
2008-003582-97
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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