Effect of Exenatide on Glucose Homeostasis Determinants in Type 2 Diabetes

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: exenatide (Byetta)

Study type: Interventional

Funder types: Other

Identifiers

NCT00948168

UCL-DIAB-01

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)