Effect of Exenatide on Glucose Homeostasis Determinants in Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

6-Months Exenatide and Glucose Homeostasis Determinants in Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948168
• Other study ID #: UCL-DIAB-01
• Status: Completed
• Phase: Phase 4
• First received: July 27, 2009
• Last updated: July 30, 2009
• Start date: July 2008
• Est. completion date: July 2009

Study information

• Verified date: July 2009
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• exenatide (Byetta)
all patients receive 5 then 10 µg exenatide subcutaneously BID for 6 months

Locations

Country	Name	City	State
Belgium	Cliniques universitaires St-Luc	Brussels	Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in HbA1c		6 months	No
Secondary	Non-invasive modeling of glucose homeostasis determinants, including insulin sensitivity		6 months	No