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
  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:


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
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: 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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014