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Clinical Trial Details

Trial ID: L6025
Source ID: NCT00676338
Associated Drug: Exenatide Once Weekly
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)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00676338/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: exenatide once weekly|DRUG: metformin|DRUG: sitagliptin|DRUG: pioglitazone
Outcome Measures: Primary: Change in HbA1c From Baseline to Week 26, Change in HbA1c from baseline to Week 26., Baseline, Week 26|Percentage of Patients Achieving HbA1c <=7% at Week 26, Percentage of patients achieving HbA1c \<=7% at Week 26 (for patients with baseline HbA1c \>7%)., Baseline, Week 26 | Secondary: Change in Fasting Serum Glucose (FSG) From Baseline to Week 26, Change in FSG from baseline to Week 26., Baseline, Week 26|Change in Body Weight From Baseline to Week 26, Change in Body Weight from baseline to Week 26., Baseline, Week 26|Change in Fasting Total Cholesterol (TC) From Baseline to Week 26, Change in Fasting TC from baseline to Week 26., Baseline, Week 26|Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26, Change in Fasting HDL from baseline to Week 26., Baseline, Week 26|Ratio of Fasting Triglycerides at Week 26 to Baseline, Ratio of Fasting Triglycerides (measured in mmol/L) at Week 26 to baseline. Log(Post-baseline Triglycerides) - log(Baseline Triglycerides); change from baseline to Week 26 is presented as ratio of endpoint to baseline., Baseline, Week 26|Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events, Major hypoglycemia is defined as any event that has symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose, or documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) requiring the assistance of another person because of severe impairment in consciousness or behavior (whether or not symptoms of hypoglycemia are detected by the patient). Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)\*\*2)., Baseline to Week 26|Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events, Minor hypoglycemia is defined as a sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)\*\*2)., Baseline to Week 26|Change in Systolic Blood Pressure From Baseline to Week 26., Change in Systolic Blood Pressure from baseline to Week 26., Baseline, Week 26|Change in Diastolic Blood Pressure From Baseline to Week 26., Change in Diastolic Blood Pressure from baseline to Week 26., Baseline, Week 26
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 820
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2008-11
Completion Date: 2011-01
Results First Posted: 2012-11-26
Last Update Posted: 2015-04-09
Locations: Research Site, Buena Park, California, United States|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
URL: https://clinicaltrials.gov/show/NCT00676338

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details
D336 Pioglitazone small molecule DB01132 Details