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OpenTrials
Completed

NCT Number: NCT00099320

Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.

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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

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Treated with thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening.
  • HbA1c between 7.1% and 10.0%, inclusive.
  • Body mass index (BMI) between 25 kg/m^2 and 45 kg/m^2.

Exclusion criteria

  • Patient previously in a study using exenatide or GLP-1 analogs.
  • Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening.
  • Treated with oral insulin within 3 months of screening.

Treatment and study plan

exenatide

Drug

After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer 20 mcg of exenatide (2 units [5 μg] ), twice daily by subcutaneous injection, for the first 4 weeks of therapy, and then 40 μL of study drug (4 units [10 μg] of exenatide) twice daily by subcutaneous injection, for the remaining 12 weeks of therapy.

Other names: Byetta, AC2993, synthetic exendin-4

Placebo

Drug

After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer placebo (in equivalent amounts to exenatide) for 16 weeks of therapy.

Primary outcomes

  1. Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16, and if measured, any visits in between

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 16

    Change in HbA1c from Baseline (Visit 3) to study termination at Week 16, and at all study visits in between

  2. Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose

    Time frame: Baseline, Week 16

    Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)

Secondary outcomes

  1. Percentage of subjects reaching the target HbA1c (<7%)

    Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

    The percentage of subjects reaching the target HbA1c (<7%) will be summarized and compared by treatment

  2. Change in body weight from Baseline to Week 16

    Time frame: Baseline, Week 16

    Change in body weight (kg) from Baseline to Week 16

  3. Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose

    Time frame: Baseline, Week 16

    Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)

  4. Changes in beta cell function and insulin sensitivity between Baseline and Week 16

    Time frame: Baseline, Week 16

    Changes in beta cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses and the proinsulin/insulin ratio Between Baseline and Week 16

  5. Changes in lipids between Baseline and Week 16

    Time frame: Baseline, Week 16

    Changes from Baseline to Week 16 in serum lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL-C], fasting triglycerides, calculated low-density lipoprotein cholesterol [LDL-C]

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Dec 13, 2004
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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