Effect of Exenatide on Glucose Homeostasis Determinants in Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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exenatide (Byetta)

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Service d'Endocrinologie et Nutrition, Cliniques universitaires St-Luc, Brussels

Locations

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Cliniques universitaires St-Luc

Brussels, Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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UCL-DIAB-01

Identifier Type: -

Identifier Source: org_study_id