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Completed

NCT Number: NCT00241423

Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes

The purpose of this study is to test the hypothesis that in patients with type 2 diabetes, the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour period, compared with placebo.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Washington D.C., District of Columbia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject has an HbA1c between 7.0% and 10.0%, inclusive.
  • Subject has a body mass index (BMI) >25 kg/m^2 and <50 kg/m^2.
  • Subject is on a stable dose of metformin or metformin plus a thiazolidinedione.

Exclusion criteria

  • Subject has been treated with any of the following medications: *exogenous insulin for more than 1 week within 3 months of screening, *sulfonylureas or meglitinides within 2 months of screening, *alpha-glucosidase inhibitors within 2 months of screening, *pramlintide acetate injection within 2 months of screening.
  • Subject has received exenatide, GLP-1 analogs, DPP-IV inhibitors, or has participated in this study previously.

Treatment and study plan

exenatide

Drug

subcutaneous injection, 5mcg twice a day for one week; then 10 mcg twice a day for one week

Other names: Byetta, AC2993, synthetic enxendin-4

Placebo

Drug

subcutaneous injection, equivalent volume to 5 mcg exenatide twice a day for one week; then equivalent volume to 10 mcg exenatide twice a day for one week

Primary outcomes

  1. Time-averaged serum glucose during a 24-hour period

    Time frame: Every half-hour to hour for 24 hours

    Time-averaged serum glucose during a 24-hour period

Secondary outcomes

  1. To compare the effects of exenatide and placebo on serum glucose

    Time frame: Each half-hour to 2 hours for 24 hours

    To compare the effects of exenatide and placebo on serum glucose measured as averaged daytime glucose, averaged nighttime glucose, time-averaged postprandial glucose 2 hours after each meal, time-averaged postprandial glucose 4 hours after each meal, 2-hour postprandial glucose averaged across morning and evening meals, and averaged across the three meals, and fluctuation evaluations

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes Using Metformin or Metformin Plus a Thiazolidinedione

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Oct 19, 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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