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Completed

NCT Number: NCT00948168

Effect of Exenatide on Glucose Homeostasis Determinants in Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cliniques universitaires St-Luc

Brussels, Brabant, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exenatide (Byetta)

Drug

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

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

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

6-Months Exenatide and Glucose Homeostasis Determinants in Type 2 Diabetic Patients

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 29, 2009
Registry last updated
Jul 31, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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