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Clinical Trial Details

Trial ID: L6939
Source ID: NCT02229383
Associated Drug: Exenatide
Title: Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02229383/results
Conditions: Diabetes Mellitus
Interventions: DRUG: Exenatide|DRUG: Exenatide matching placebo
Outcome Measures: Primary: Change in HbA1c From Baseline to Week 28, To compare the change from baseline in HbA1c achieved with exenatide once weekly (EQW) added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. SU= sulfonylurea., Baseline to Week 28 | Secondary: Change in Body Weight From Baseline to Week 28, To compare the change from baseline in body weight achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment., Baseline to Week 28|Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT), To compare the change from baseline in 2-hour postprandial glucose after a standard MTT achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment., Baseline to Week 28|Percentage of Participants Achieving HbA1c <7.0% at Week 28, To compare the percentage of participants achieving HbA1c \<7.0% between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment., Baseline to Week 28|Change From Baseline to Week 28 in Daily Insulin Dose, To compare the change from baseline in daily insulin dose achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment., Baseline to Week 28|Percentage of Participants Achieving HbA1c <7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks, To compare the percentage of participants achieving HbA1c \<7.0% at Week 28, no weight gain at Week 28, and no major hypoglycemia over 28 weeks between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin., Baseline to Week 28|Change in Seated Systolic Blood Pressure From Baseline to Week 28, To compare the change from baseline in seated systolic blood pressure achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment., Baseline to Week 28
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 464
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-09-06
Completion Date: 2016-08-29
Results First Posted: 2017-09-18
Last Update Posted: 2019-01-08
Locations: Research Site, Birmingham, Alabama, 35235, United States|Research Site, Huntsville, Alabama, 35801, United States|Research Site, Muscle Shoals, Alabama, 35662, United States|Research Site, Tempe, Arizona, 85283, United States|Research Site, Chino, California, 91710, United States|Research Site, Chula Vista, California, 91910, United States|Research Site, El Cajon, California, 92020, United States|Research Site, Fresno, California, 93720, United States|Research Site, Long Beach, California, 90807, United States|Research Site, Los Angeles, California, 90057, United States|Research Site, Mission Hills, California, 91345, United States|Research Site, Tustin, California, 92780, United States|Research Site, West Hills, California, 91307, United States|Research Site, Boynton Beach, Florida, 33437, United States|Research Site, Brooksville, Florida, 34601, United States|Research Site, Chiefland, Florida, 32626, United States|Research Site, Clearwater, Florida, 33765, United States|Research Site, Coral Gables, Florida, 33134, United States|Research Site, Fort Lauderdale, Florida, 33316, United States|Research Site, Hialeah, Florida, 33012, United States|Research Site, Jacksonville, Florida, 32256, United States|Research Site, Jacksonville, Florida, 32277, United States|Research Site, Miami, Florida, 33125, United States|Research Site, Miami, Florida, 33126, United States|Research Site, Miami, Florida, 33133, United States|Research Site, Miami, Florida, 33142, United States|Research Site, Miami, Florida, 33175, United States|Research Site, North Miami Beach, Florida, 33162, United States|Research Site, Orlando, Florida, 32806, United States|Research Site, Tampa, Florida, 33603, United States|Research Site, Columbus, Georgia, 31406, United States|Research Site, Chicago, Illinois, 60607, United States|Research Site, Avon, Indiana, 46123, United States|Research Site, Evansville, Indiana, 47714, United States|Research Site, Franklin, Indiana, 46131, United States|Research Site, Newton, Kansas, 67114, United States|Research Site, Monroe, Louisiana, 71203, United States|Research Site, New Orleans, Louisiana, 70112, United States|Research Site, Hazelwood, Missouri, 63042, United States|Research Site, Bellevue, Nebraska, 68005, United States|Research Site, Omaha, Nebraska, 68114, United States|Research Site, Haddon Heights, New Jersey, 08035, United States|Research Site, Mooresville, North Carolina, 28117, United States|Research Site, Morehead City, North Carolina, 28557, United States|Research Site, Morganton, North Carolina, 28655, United States|Research Site, Cincinnati, Ohio, 45242, United States|Research Site, Cleveland, Ohio, 44122, United States|Research Site, Dayton, Ohio, 45417, United States|Research Site, Medford, Oregon, 97504, United States|Research Site, Philadelphia, Pennsylvania, 91307, United States|Research Site, Greer, South Carolina, 29651, United States|Research Site, Spartanburg, South Carolina, 29303, United States|Research Site, Dakota Dunes, South Dakota, 57049, United States|Research Site, Johnson City, Tennessee, 37604, United States|Research Site, Kingsport, Tennessee, 37660, United States|Research Site, Austin, Texas, 78705, United States|Research Site, Dallas, Texas, 75208, United States|Research Site, Dallas, Texas, 75230, United States|Research Site, Houston, Texas, 77030, United States|Research Site, Houston, Texas, 77070, United States|Research Site, Houston, Texas, 77079, United States|Research Site, Houston, Texas, 77090, United States|Research Site, Clinton, Utah, 84015, United States|Research Site, Ogden, Utah, 84405, United States|Research Site, Salt Lake City, Utah, 84102, United States|Research Site, Manassas, Virginia, 20110, United States|Research Site, Richmond, Virginia, 23294, United States|Research Site, Port Orchard, Washington, 98366, United States|Research Site, Baja, 6500, Hungary|Research Site, Balatonfured, 8230, Hungary|Research Site, Budapest, 1033, Hungary|Research Site, Budapest, 1036, Hungary|Research Site, Budapest, 1083, Hungary|Research Site, Budapest, 1088, Hungary|Research Site, Budapest, 1134, Hungary|Research Site, Debrecen, 4032, Hungary|Research Site, Eger, 3300, Hungary|Research Site, Gyula, 5700, Hungary|Research Site, Gödöllő, 2100, Hungary|Research Site, Komárom, 2921, Hungary|Research Site, Létavértes, 4281, Hungary|Research Site, Pécs, 7623, Hungary|Research Site, Satoraljaujhely, 3980, Hungary|Research Site, Szeged, 6722, Hungary|Research Site, Szekszárd, 7100, Hungary|Research Site, Lublin, 20-363, Poland|Research Site, Lublin, 20-538, Poland|Research Site, Oświęcim, 32-600, Poland|Research Site, Poznań, 61-655, Poland|Research Site, Torun, 87-100, Poland|Research Site, Zamość, 22-400, Poland|Research Site, Zgierz, 95-100, Poland|Research Site, Łódź, 94-048, Poland|Research Site, Baia Mare, 430222, Romania|Research Site, Bucuresti, 010192, Romania|Research Site, Bucuresti, 010825, Romania|Research Site, Bucuresti, 020475, Romania|Research Site, Galati, 800578, Romania|Research Site, Oradea, 410032, Romania|Research Site, Oradea, 410169, Romania|Research Site, Ploiesti, 100342, Romania|Research Site, Tg Mures, 540142, Romania|Research Site, Timișoara, 300456, Romania|Research Site, Bardejov, 08501, Slovakia|Research Site, Bratislava, 81108, Slovakia|Research Site, Bratislava, 82106, Slovakia|Research Site, Dolny Kubin, 026 01, Slovakia|Research Site, Kosice, 04001, Slovakia|Research Site, Levice, 934 01, Slovakia|Research Site, Levice, 93401, Slovakia|Research Site, Lucenec, 984 01, Slovakia|Research Site, Nitra, 94901, Slovakia|Research Site, Nitra, 94911, Slovakia|Research Site, Presov, 080 01, Slovakia|Research Site, Sturovo, 94301, Slovakia|Research Site, Bloemfontein, 9301, South Africa|Research Site, Kempton Park, 1619, South Africa|Research Site, Krugersdorp, 1739, South Africa|Research Site, Paarl, 7646, South Africa|Research Site, Pretoria, 0087, South Africa|Research Site, Pretoria, 184, South Africa|Research Site, Somerset West, 7130, South Africa|Research Site, Worcester, 6850, South Africa
URL: https://clinicaltrials.gov/show/NCT02229383

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