Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3830
Source ID: NCT00082381
Associated Drug: Exenatide (Ac2993)
Title: Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00082381/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Exenatide (AC2993)|DRUG: Insulin glargine
Outcome Measures: Primary: Change in Glycosylated Hemoglobin (HbA1c), Change in HbA1c from baseline to week 26, Baseline, week 26 | Secondary: Percentage of Patients Achieving HbA1c <=7%, Percentage of patients in each arm who had HbA1c \>7% at baseline and had HbA1c \<=7% at week 26 (percentage = \[number of subjects with HbA1c \<=7% at week 26 divided by number of subjects with HbA1c \>7% at baseline\] \* 100%)., 26 weeks|Change in Body Weight, Change in body weight from baseline to week 26, Baseline, week 26|Change in Fasting Serum Glucose, Change in fasting serum glucose from baseline to week 26, Baseline, week 26|Change in 7-point Self-monitored Blood Glucose (SMBG) Profile, Change in 7-point (pre-breakfast, 2 hour post breakfast, pre-lunch, 2 hour post lunch, pre-dinner, 2 hour post dinner, 0300 hours) SMBG profile from baseline to week 26, Baseline, week 26|Percentage of Patients With Hypoglycemic Events, Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study divided by the total number of patients who participated in the 26 week Parent Study, 26 weeks|Change in Rate of Hypoglycemic Events, Change in rate of hypoglycemic events per 30 days per patient 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: 551
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2003-06
Completion Date: 2008-07
Results First Posted: 2013-07-31
Last Update Posted: 2015-04-07
Locations: Radiant Research-San Diego, San Diego, California, 92108, United States|Dorothy L. and James E. Frank Diabetes Research Institute, San Mateo, California, 94401, United States|Internal Medicine Associates Department of Research, Fort Myers, Florida, 33901, United States|Jacksonville Center for Clinical Research, Jacksonville, Florida, 32216, United States|Baptist Diabetes Associates, Miami, Florida, 33176, United States|Metabolic Research Institute, Inc., West Palm Beach, Florida, 33401, United States|Springfield Diabetes & Endocrine Center, Springfield, Illinois, 62704, United States|Frederick Primary Care Associates, Frederick, Maryland, 21702, United States|Radiant Research, Inc., St. Louis, Missouri, 63141, United States|Lovelace Scientific Resources, Inc., Las Vegas, Nevada, 89102, United States|Diabetes, Endocrine & Nutrition, Hampton, New Hampshire, 03842, United States|Lovelace Scientific Resources, Albuquerque, New Mexico, 87108, United States|Great Lakes Medical Research, Westfield, New York, 14787, United States|DOCS, Beth Israel Medical Center, Yonkers, New York, 10710, United States|Piedmont Medical Research Associates, Winston-Salem, North Carolina, 27103, United States|Jon Shapiro, MD, Philadelphia, Pennsylvania, 19146, United States|Endocrinology Consultants of East Tennessee, Knoxville, Tennessee, 37909, United States|Israel Hartman, MD, Arlington, Texas, 76014, United States|Diabetes & Glandular Research Associates, P.A., San Antonio, Texas, 78229, United States|Jack Wahlen, MD, Ogden, Utah, 84403, United States|Rainier Clinical Research Center, Inc., Renton, Washington, 98055, United States|Australian Clinical Research Centre, Miranda, New South Wales, 2228, Australia|Royal North Shore Hospital, St. Leonards, New South Wales, 2065, Australia|Clinical Trial and Research Unit, Wollongong, New South Wales, 2500, Australia|Royal Brisbane Hospital, Brisbane, Queensland, 4029, Australia|Royal Adelaid Hospital, Adelaid, South Australia, 5000, Australia|Repatriation General Hospital, Daw Park, South Australia, 5041, Australia|SA Endocrine Clinical Research, Keswick, South Australia, 5035, Australia|Eastern Health (Box Hill Hospital), Box Hill, Victoria, 3128, Australia|Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia|Freemantle Hospital, Freemantle, Western Australia, Australia|UZ Antwerpen, Endegem, 2650, Belgium|UZ Gent, Gent, 9000, Belgium|UZ Gasthuisberg, Leuven, 3000, Belgium|CHU Sart Tilman, Liege, 4000, Belgium|A.Z. Jan Palfijn, Merksem, 2170, Belgium|Sint Niklaasstraat, Sint Gillis Waas, 9170, Belgium|Hospital Nossa Senhora das Gracas, Curitiba, PR 80810-990, Brazil|Centro Integrado de Diabetes e Hipertensao, Fortaleza, CE 601200-020, Brazil|Centro de Pesquisas em Diabetes e Doencas Endocrino Metabolicas/HUWC/UFC, Fortaleza, CE 60430-350, Brazil|Santa Casa de Misericordia de Porto Alegre, Porto Alegre, RS 90020-090, Brazil|Eiran Sairaala c/o9 Clires, Helsinki, Finland|Torikeskuksen Laakariasema, Yliopistonkatu, Jyvaskyla, Finland|Oulu Deakoness Institution, Oulu, 90100, Finland|Diabetologische Schwerpunktpraxis, Aschaffenburg, 63739, Germany|Diabetologische Scherpunktpraxis, Bosenheim, 55545, Germany|Diabetologische Schwerpunktpraxis, Dortmund, 44137, Germany|Krankenhaus Bethanien, Hamburg, 20251, Germany|Universitatskliniken des Saarlandes, Homburg/Saar, 66421, Germany|IKFE GmbH, Mainz, Germany|Profil Institut fur Stoffwechselforschung GmbH, Neuss, Germany|Diabetologische Schwerpunktpraxis, Neuwied, 56564, Germany|Diabetes Centrum Bilthoven, Bilthoven, 3723 MB, Netherlands|Atrium Medisch Centrum Brunssum, Brunssum, 6422 BE, Netherlands|Sint Antonius Ziekenhuis Nieuwegein, Nieuwegein, 3435 CM, Netherlands|Refaja ziekenhuis, Stadskanaal, 9501 HE, Netherlands|Medisch Centrum, Westeinde, Netherlands|Markeveien Spesialistpraksis, Bergen, 5012, Norway|Spesiallegetjenesten AS, Jessheim, 2050, Norway|Betanien Spesialistsenter, Oslo, 0172, Norway|Sykehuset Asker of Baerum HF, Rud, 1309, Norway|Forskningsstiftelsen Hjertelaget, Stravanger, 4011, Norway|Bydgoskie Centrum Diabetologii i Endokrynologii, Bydgoszcz, 85-822, Poland|Oddzial Chorob Wewnetrznych, Czestochowa, 42-200, Poland|NZOZ "Diab-Endo-Met", Krakow, Poland|Poradnia Diabetologiczna, Lodz, Rzgowska 281/289, Poland|Poradnia Diabetologiczna, Lublin, 20-718, Poland|Oddzial Chorob Wewnetrznych, Mielec, 39-300, Poland|Oddzial Chorob Wewnetrznych i Diabetologii, Warszawa, 02-507, Poland|Wojewodzka Poradnia dla Chorych na Cukrzyce, Warszawa, 03-242, Poland|Hospital Garcia de Orta-Servico de Endocrinologia, Almada, 2805-267, Portugal|Centro Hospitalar de Coimbra, Coimbra, 3040-853, Portugal|Associacao Protectora dos Diabeticos de Portugal, Lisboa, 1250-203, Portugal|Hospital Geral de Santo Antonio, Porto, 4099-001, Portugal|Universidad Central del Caribe, Bayamon, 00956, Puerto Rico|Hospital Alejandro Otero Lopez, Manati, 00674, Puerto Rico|Dr. Luis Ruiz, Ponce, 00733, Puerto Rico|RCMI-Clinical Research Center, Rio Piedras, 00935, Puerto Rico|San Juan Health Center, San Juan, 00936-3833, Puerto Rico|Centro de Endocrinologia del Este, Yabucoa, 00767, Puerto Rico|Hospital Vega Baja, Alicante, 03300, Spain|Hospital Doce de Octubre, Madrid, 28041, Spain|Hospital Gral de Mostoles, Madrid, 28934 Mostoles, Spain|Hospital Virgen de Valme, Sevilla, 41014, Spain|Hospital la Ribera, Alzira, Valencia, 46600 Alzira, Spain|Lundberglaboratoriet for diabetesforskning, Goteborg, 413 45, Sweden|Medicinska kliniken, Helsingborg, 251 87, Sweden|Kliniska Forskningsenheren, Lund, 221 85, Sweden|Diabetesmottagningen, Intermedicinska kliniken, Stockholm, 118 83, Sweden|CME, M71, Stockholm, 141 86, Sweden|Enheten for metabol kontroll, Stockholm, 171 76, Sweden
URL: https://clinicaltrials.gov/show/NCT00082381

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress