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Effect of Exenatide on Glucose Homeostasis Determinants in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00948168
First received: July 27, 2009
Last updated: July 30, 2009
Last verified: July 2009
History of Changes
  Purpose

The purpose of this study is to determine in type 2 diabetic patients in secondary failure to combined oral therapy whether, besides improvement in glycemic control, addition of exenatide, a new drug introduced to treat diabetes before addition of insulin to current therapy, over 6 months is associated with improvement in beta-cell function, insulin sensitivity following 24-hours discontinuation of the drug.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: exenatide (Byetta)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 6-Months Exenatide and Glucose Homeostasis Determinants in Type 2 Diabetic Patients

Resource links provided by NLM:

Drug Information available for: Exenatide
U.S. FDA Resources

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Improvement in HbA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non-invasive modeling of glucose homeostasis determinants, including insulin sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: July 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: exenatide (Byetta)
    all patients receive 5 then 10 µg exenatide subcutaneously BID for 6 months
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 2 diabetes subjects
  • 40 to 80 years
  • body mass index (BMI) between 25 and 40 kg/m²
  • baseline glycated haemoglobin (HbA1c) > 7.0 %, despite a maximally-tolerated combined oral therapy with a BCF stimulant (sulfonylurea or repaglinide) plus metformin

Exclusion Criteria:

  • previous or current use of glitazone
  • previous use of systemic glucocorticoids, weight-reducing drug(s) such as sibutramine
  • previous exposure to GLP-1 receptor agonist or DPP-4 inhibitors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948168

Locations
Belgium
Cliniques universitaires St-Luc
Brussels, Brabant, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  More Information

No publications provided

Responsible Party: Service d'Endocrinologie et Nutrition, Cliniques universitaires St-Luc, Brussels
ClinicalTrials.gov Identifier: NCT00948168     History of Changes
Other Study ID Numbers: UCL-DIAB-01
Study First Received: July 27, 2009
Last Updated: July 30, 2009
Health Authority: Belgium: Institutional Review Board

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
T2DM
exenatide
HbA1c
weight
 waist circumference
insulin sensitivity
beta-cell function

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013