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: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: taspoglutide
Drug: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: November 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: taspoglutide
300micrograms/day sc for 2 days
Drug: taspoglutide
800 micrograms/day sc for 2 days
Drug: Placebo
sc for 4 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811460

Locations
Germany
Neuss, Germany, 41460
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: NCT00811460     History of Changes
Other Study ID Numbers: BP21844, 2008-003582-97
Study First Received: December 18, 2008
Last Updated: July 7, 2014
Health Authority: Germany:BfArM

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

ClinicalTrials.gov processed this record on July 24, 2014