Type 2 Diabetes Mellitus
Conditions
Keywords
T2DM, exenatide, HbA1c, weight, waist circumference, insulin sensitivity, beta-cell function
Brief 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.
Interventions
DRUGexenatide (Byetta)
all patients receive 5 then 10 µg exenatide subcutaneously BID for 6 months
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in HbA1c | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Non-invasive modeling of glucose homeostasis determinants, including insulin sensitivity | 6 months |
Countries
Belgium
Outcome results
None listed