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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: taspoglutide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Tmax, log (AUC), log(Cmax)of paracetamol [ Time Frame: Days -1, 1, 5, 29, 33, 78 and 82 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: December 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: taspoglutide
10mg sc once weekly for 12 weeks
Experimental: 2 Drug: taspoglutide
10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks
Placebo Comparator: 3 Drug: Placebo
sc once weekly for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809705

Locations
Germany
Berlin, Germany, 14050
Neuss, Germany, 41460
United Kingdom
London, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00809705     History of Changes
Other Study ID Numbers: BP21572, 2008-003575-47
Study First Received: December 16, 2008
Last Updated: April 7, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014