Effect of Exenatide on Glucose Homeostasis Determinants in Type 2 Diabetes

Cliniques universitaires Saint-Luc- Université Catholique de Louvain34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

exenatide (Byetta)DRUG

all patients receive 5 then 10 µg exenatide subcutaneously BID for 6 months

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Cliniques universitaires St-Luc

Brussels, Brabant, Belgium

Outcomes

Primary Outcomes

Improvement in HbA1c

Time frame: 6 months

Secondary Outcomes

Non-invasive modeling of glucose homeostasis determinants, including insulin sensitivity

Time frame: 6 months

Data from ClinicalTrials.gov

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