Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4) 


Tracking Information

Start Date  ICMJENovember 2008
Estimated Primary Completion DateSeptember 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2008)
Test hypothesis that exenatide once weekly is superior to metformin, sitagliptin, and pioglitazone in HbA1c reduction at 26 weeks compared to baseline, in drug-naive patients with type 2 diabetes who are inadequately treated with diet and exercise. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00676338 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: May 9, 2008)
  • Compare exenatide once weekly to metformin, sitagliptin, and pioglitazone with respect to HbA1c, change in fasting serum glucose, change in body weight, self-monitored blood glucose profile, and change in serum lipids. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Compare exenatide once weekly to metformin, sitagliptin, and pioglitazone with respect to incidence of hypoglycemic events, change in blood pressure, safety and tolerability, and health outcomes. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJESafety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)
Official Title  ICMJESafety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes
Brief Summary

This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEType 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: exenatide once weekly
    subcutaneous injection, 2mg, once weekly
  • Drug: metformin
    oral, 1000-2500mg, daily
  • Drug: sitagliptin
    oral, 100 mg, daily
  • Drug: pioglitazone
    oral, 30-45mg, daily
Study Arms / Comparison Groups
  • 1: Experimental
    Intervention: Drug: exenatide once weekly
  • 2: Active Comparator
    Intervention: Drug: metformin
  • 3: Active Comparator
    Intervention: Drug: sitagliptin
  • 4: Active Comparator
    Intervention: Drug: pioglitazone

Recruitment Information

Estimated Enrollment  ICMJE822
Estimated Completion DateSeptember 2010
Estimated Primary Completion DateSeptember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • have type 2 diabetes and are treated with diet and exercise alone.
  • at least 18 years of age.
  • HbA1c between 7.1% and 11.0%, inclusive.
  • Body mass index (BMI) of 23 kg/m2 to 45 kg/m2, inclusive.
  • Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).

Exclusion Criteria:

  • Have history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty
  • Have a history of renal transplantation or are currently receiving renal dialysis
  • Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
  • Have history of severe GI disorder (e.g., gastroparesis)
  • Have a history of acute or chronic pancreatitis.
  • Have active proliferative retinopathy.
  • Have been treated with drugs that promote weight loss (e.g., Xenical®[orlistat], Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
  • Have been treated with any antidiabetic agent for more than 7 days within 3 months prior to screening.
  • Have had an organ transplant.
  • Have previously completed or discontinued study drug in this study, withdrawn from this study or any other study investigating exenatide once weekly.
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Are currently enrolled in any other clinical study.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Lilly Clinical Trials Support Center1-877-CTLILLY (1-877-285-4559)
Location Countries  ICMJEUnited States,   Argentina,   Belgium,   Brazil,   Canada,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Mexico,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Turkey,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00676338
Responsible PartyStudy Director, Eli Lilly and Company
Study ID Numbers  ICMJEH8O-MC-GWCH (DURATION - 4)
Study Sponsor  ICMJEAmylin Pharmaceuticals, Inc.
Collaborators  ICMJEEli Lilly and Company
Investigators  ICMJE
Study Director:Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Eli Lilly and Company
Information Provided ByAmylin Pharmaceuticals, Inc.