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)
Overview[ - collapse ][ - ]
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. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: exenatide once weekly Drug: metformin Drug: sitagliptin Drug: pioglitazone |
Phase | Phase 3 |
Sponsor | Bristol-Myers Squibb |
Responsible Party | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier | NCT00676338 |
First Received | May 9, 2008 |
Last Updated | September 17, 2013 |
Last verified | September 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | May 9, 2008 |
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Last Updated Date | September 17, 2013 |
Start Date | November 2008 |
Estimated Primary Completion Date | January 2011 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief 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 (DURATION-4) |
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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 |
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 | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: exenatide once weekly subcutaneous injection, 2mg, once weekly plus placebo oral once daily Drug: metformin oral, 1000-2500mg, daily plus placebo once weekly subcutaneous injection Drug: sitagliptin oral, 100 mg, daily plus placebo once weekly subcutaneous injection Drug: pioglitazone oral, 30-45mg, daily plus placebo once weekly subcutaneous injection |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 820 |
Estimated Completion Date | January 2011 |
Estimated Primary Completion Date | July 2010 |
Eligibility 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. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United 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[ + expand ][ + ]
NCT Number | NCT00676338 |
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Other Study ID Numbers | H8O-MC-GWCH (DURATION - 4) |
Has Data Monitoring Committee | No |
Information Provided By | Bristol-Myers Squibb |
Study Sponsor | Bristol-Myers Squibb |
Collaborators | Eli Lilly and Company |
Investigators | Study Director: Chief Medical Officer, MD Eli Lilly and Company |
Verification Date | September 2013 |
Locations[ + expand ][ + ]
Research Site | Buena Park, California, United States |
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Research Site | Los Angeles, California, United States |
Research Site | Valencia, California, United States |
Research Site | Jacksonville, Florida, United States |
Research Site | Atlanta, Georgia, United States |
Research Site | Meridian, Idaho, United States |
Research Site | Des Moines, Iowa, United States |
Research Site | Grand Rapids, Michigan, United States |
Research Site | Minneapolis, Minnesota, United States |
Research Site | Billings, Montana, United States |
Research Site | Toms River, New Jersey, United States |
Research Site | Wilmington, North Carolina, United States |
Research Site | Danville, Pennsylvania, United States |
Research Site | Philadelphia, Pennsylvania, United States |
Research Site | Wilke Barre, Pennsylvania, United States |
Research Site | Austin, Texas, United States |
Research Site | El Paso, Texas, United States |
Research Site | New Branufels, Texas, United States |
Research Site | Buenos Aires, Argentina |
Research Site | Mar del Plata, Argentina |
Research Site | Leuven, Belgium |
Research Site | Marchovelette, Belgium |
Research Site | Tessenderlo, Belgium |
Research Site | Brasilia, Brazil |
Research Site | Campinas, Brazil |
Research Site | Curitiba, Brazil |
Research Site | Fortaleza, Brazil |
Research Site | Joinville, Brazil |
Research SIte | Porto Alegre, Brazil |
Research Site | Recife, Brazil |
Research Site | Sao Paolo, Brazil |
Research Site | Coquitlam, British Columbia, Canada |
Research Site | Penticton, British Columbia, Canada |
Research Site | Ottawa, Ontario, Canada |
Research Site | Gatineu, Quebec, Canada |
Research Site | Mississauga, Canada |
Research Site | Petitcodiac, Canada |
Research Site | Pointe-Claire, Canada |
Research Site | Regina, Canada |
Research Site | Saint John, Canada |
Research Site | Chateaugiron, France |
Research Site | Murs Erigne, France |
Research Site | Nantes, France |
Research Site | Vieux Conde, France |
Research Site | Dresden, Germany |
Research Site | Mainz, Germany |
Research Site | Muenster, Germany |
Research Site | Rodgau, Germany |
Research Site | Budapest, Hungary |
Research Site | Gyula, Hungary |
Research Site | Hodmezovasarhely, Hungary |
Research Site | Pecs, Hungary |
Research Site | Ahmedabad, India |
Research Site | Bangalore, India |
Research Site | Channai, India |
Research Site | Cochin, India |
Research Site | Mumbai, India |
Research Site | New Dehli, India |
Research SIte | Pune, India |
Research Site | Holon, Israel |
Research SIte | Tel-Hashomer, Israel |
Research Site | Firenze, Italy |
Research Site | Milano, Italy |
Research Site | Siena, Italy |
Research Site | Busan, Korea, Republic of |
Research Site | Daegu, Korea, Republic of |
Research Site | Jeonju, Korea, Republic of |
Research Site | Seoul, Korea, Republic of |
Research Site | Sungnam, Korea, Republic of |
Research Site | Chihuahua, Mexico |
Research Site | Guadalajara, Mexico |
Research Site | Monterrey, Mexico |
Research Site | Lublin, Poland |
Research Site | Szczecin, Poland |
Research Site | Wroclaw, Poland |
Research Site | Manati, Puerto Rico |
Research Site | Toa Baja, Puerto Rico |
Research Site | Galati, Romania |
Research Site | Oradea, Romania |
Research Site | Targu Mures, Romania |
Research Site | Arkhangelsk, Russian Federation |
Research Site | Moscow, Russian Federation |
Research Site | Rostov-on-Don, Russian Federation |
Research Site | Saint Petersburg, Russian Federation |
Research Site | Stavropol, Russian Federation |
Research Site | Bratislava, Slovakia |
Research Site | Trebisov, Slovakia |
Research Site | Johannesburg, South Africa |
Research Site | Kempton Park, South Africa |
Research Site | Midrand, South Africa |
Research Site | Soweto, South Africa |
Research Site | Alicante, Spain |
Research Site | Barcelona, Spain |
Research Site | Madrid, Spain |
Research Site | Sevilla, Spain |
Research Site | Ankara, Turkey |
Research Site | Istanbul, Turkey |
Research Site | Sisli-Istanbul, Turkey |
Research Site | Bath, United Kingdom |
Research Site | Birmingham, United Kingdom |
Research Site | Edinburgh, United Kingdom |
Research Site | Frome, United Kingdom |
Research Site | Guildford, United Kingdom |
Research Site | Hull, United Kingdom |
Research Site | Sheffield, United Kingdom |
Research Site | Swansea, United Kingdom |