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CompletedNCT00948168Updated Jul 31, 2009

Effect of Exenatide on Glucose Homeostasis Determinants in Type 2 Diabetes

A Phase 4 interventional study of exenatide (Byetta) in Type 2 Diabetes Mellitus, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-07-31.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
34
Allocation
Non-randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • T2DM
  • exenatide
  • HbA1c
  • weight
  • waist circumference
  • insulin sensitivity
  • beta-cell function
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 34 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Interventions

  • Drugexenatide (Byetta)

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

06

What researchers measure

Primary outcomes

  1. Improvement in HbA1c

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

07

Study locations

1 site
  • Cliniques universitaires St-Luc
    Brussels, Brabant 1200, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00948168
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
First posted
Jul 29, 2009
Start date
Jul 2008
Primary completion
Jul 2009
Completion
Jul 2009
Last update
Jul 31, 2009

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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