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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00809705
First Posted: December 17, 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 16, 2008
December 17, 2008
November 2, 2016
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 ]
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 ]
  • renal function (creatinine clearance, urine volume and electrolytes) [ Time Frame: Throughout study ]
  • Multiple dose pharmacokinetics of Taspoglutide [ Time Frame: Throughout study ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus Type 2
  • Drug: Placebo
    sc once weekly for 12 weeks
  • Drug: taspoglutide
    10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United Kingdom
 
 
NCT00809705
BP21572
2008-003575-47
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