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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00099320
First received: December 10, 2004
Last updated: September 18, 2013
Last verified: September 2013

December 10, 2004
September 18, 2013
May 2004
August 2005   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    Change in HbA1c from Baseline (Visit 3) to study termination at Week 16, and at all study visits in between
  • Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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)
Not Provided
Complete list of historical versions of study NCT00099320 on ClinicalTrials.gov Archive Site
  • Percentage of subjects reaching the target HbA1c (<7%) [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 ] [ Designated as safety issue: No ]
    The percentage of subjects reaching the target HbA1c (<7%) will be summarized and compared by treatment
  • Change in body weight from Baseline to Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    Change in body weight (kg) from Baseline to Week 16
  • Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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)
  • Changes in beta cell function and insulin sensitivity between Baseline and Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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
  • Changes in lipids between Baseline and Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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]
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: exenatide
    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
  • Drug: Placebo
    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.
  • Experimental: Exenatide
    After a 2-week placebo lead-in period, exenatide will be given in an esclating dose along with the subject's current therapy regimen
    Intervention: Drug: exenatide
  • Placebo Comparator: Placebo
    After a 2-week placebo lead-in period, subjects will be given placebo (in equivalent amounts to exenatide) in addition to their current therapy regimen.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
182
August 2005
August 2005   (final data collection date for primary outcome measure)

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.
Both
21 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Spain
 
NCT00099320
H8O-MC-GWAP
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Eli Lilly and Company
Study Director: James Malone, MD Eli Lilly and Company
Bristol-Myers Squibb
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP