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OpenTrials
Completed

NCT Number: NCT00111540

Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes

This open label study is designed to assess long term glucose control, as measured by hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The subject has an HbA1c value <=11.0%
  • The subject has a body mass index (BMI) of 25 kg/m^2 to 45 kg/m^2, inclusive

Exclusion criteria

  • Is currently treated with certain medications, including exogenous insulin

Treatment and study plan

exenatide

Drug

subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination

Other names: Byetta, exendin-4, AC2993

Primary outcomes

  1. Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit

    Time frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)

    Change in HbA1c from Visit 1 to each visit up to open-ended study termination

  2. Change in body weight from Visit 1 to each protocol visit

    Time frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)

    Change in body weight (kg) from Visit 1 to each visit up to open-ended study termination

  3. Change in fasting plasma glucose from Visit 1 to each protocol visit

    Time frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)

    Change in fasting plasma glucose from Visit 1 to each visit up to open-ended study termination

  4. Change in lipids from Visit 1 to each protocol visit

    Time frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)

    Change in lipids from Visit 1 to each visit up to open-ended study termination

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open Label Study to Examine the Long Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
May 24, 2005
Registry last updated
Feb 23, 2015

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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