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):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00099320
First received: December 10, 2004
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: exenatide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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]


Enrollment: 182
Study Start Date: May 2004
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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.
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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099320

  Show 51 Study Locations
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
Study Director: James Malone, MD Eli Lilly and Company
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00099320     History of Changes
Other Study ID Numbers: H8O-MC-GWAP
Study First Received: December 10, 2004
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:
exenatide
exendin-4
diabetes
Amylin
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
2,4-thiazolidinedione
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014