A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00809705
First received: December 16, 2008
Last updated: April 7, 2014
Last verified: April 2014

December 16, 2008
April 7, 2014
December 2008
October 2009   (final data collection date for primary outcome measure)
Tmax, log (AUC), log(Cmax)of paracetamol [ Time Frame: Days -1, 1, 5, 29, 33, 78 and 82 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00809705 on ClinicalTrials.gov Archive Site
  • Adverse events, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • renal function (creatinine clearance, urine volume and electrolytes) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Multiple dose pharmacokinetics of Taspoglutide [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes
A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of Taspoglutide on Gastric Emptying Measured by a Paracetamol Test After Single Dose and After Multiple Doses in Patients With Type 2 Diabetes

This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4 weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12 weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a paracetamol test at intervals during the study. The anticipated time on study treatment is 3 months, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: taspoglutide
    10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks
  • Drug: Placebo
    sc once weekly for 12 weeks
  • Drug: taspoglutide
    10mg sc once weekly for 12 weeks
  • Experimental: 1
    Intervention: Drug: taspoglutide
  • Experimental: 2
    Intervention: Drug: taspoglutide
  • Placebo Comparator: 3
    Intervention: 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
60
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes mellitus, treated with stable oral antidiabetic drug therapy for >=3 months prior to screening;
  • stable weight +/-10% for >=3 months before screening.

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • acute gastrointestinal symptoms at screening and/or day -1;
  • clinically relevant cardiovascular, bronchopulmonary, gastrointestinal or neurological disease.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United Kingdom
 
NCT00809705
BP21572, 2008-003575-47
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

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