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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)
This study is currently recruiting participants.
Verified by Amylin Pharmaceuticals, Inc., March 2009
First Received: May 9, 2008   Last Updated: March 27, 2009   History of Changes
Sponsors and Collaborators: Amylin Pharmaceuticals, Inc.
Eli Lilly and Company
Information provided by: Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00676338
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: exenatide once weekly
Drug: metformin
Drug: sitagliptin
Drug: pioglitazone
Phase III

MedlinePlus related topics: Diabetes Diets Exercise and Physical Fitness
Drug Information available for: Pioglitazone Pioglitazone hydrochloride Exenatide Sitagliptin Sitagliptin phosphate Metformin Metformin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 822
Study Start Date: November 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: exenatide once weekly
subcutaneous injection, 2mg, once weekly
2: Active Comparator Drug: metformin
oral, 1000-2500mg, daily
3: Active Comparator Drug: sitagliptin
oral, 100 mg, daily
4: Active Comparator Drug: pioglitazone
oral, 30-45mg, daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676338

Contacts
Contact: Lilly Clinical Trials Support Center 1-877-CTLILLY (1-877-285-4559)

  Show 106 Study Locations
Sponsors and Collaborators
Amylin Pharmaceuticals, Inc.
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company ( Study Director )
Study ID Numbers: H8O-MC-GWCH (DURATION - 4)
Study First Received: May 9, 2008
Last Updated: March 27, 2009
ClinicalTrials.gov Identifier: NCT00676338     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:
Amylin
Lilly
exenatide once weekly
Byetta
Januvia
sitagliptin
thiazolidinedione

Study placed in the following topic categories:
Metabolic Diseases
Exenatide
Pioglitazone
Amylin
Metformin
Diabetes Mellitus
Endocrine System Diseases
2,4-thiazolidinedione
Protease Inhibitors
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Pioglitazone
Exenatide
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
2,4-thiazolidinedione
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009