NCT00948168

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
Last Updated

July 31, 2009

Status Verified

July 1, 2009

Enrollment Period

1 year

First QC Date

July 27, 2009

Last Update Submit

July 30, 2009

Conditions

Type 2 Diabetes Mellitus

Keywords

T2DMexenatideHbA1cweightwaist circumferenceinsulin sensitivitybeta-cell function

Outcome Measures

Primary Outcomes (1)

  • Improvement in HbA1c

    6 months

Secondary Outcomes (1)

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

    6 months

Interventions

exenatide (Byetta)DRUG

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

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes subjects
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires St-Luc

Brussels, Brabant, 1200, Belgium

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Body WeightInsulin Resistance

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinism

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 27, 2009

First Posted

July 29, 2009

Study Start

July 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

July 31, 2009

Record last verified: 2009-07

Locations

BE(1)