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| Sponsor: | Amylin Pharmaceuticals, Inc. |
|---|---|
| Collaborator: |
Eli Lilly and Company |
| Information provided by: | Amylin Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00082381 |
Purpose
This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: AC2993 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Effect of AC2993 (Synthetic Exendin-4) Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin |
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, California | |
| Dorothy L. and James E. Frank Diabetes Research Institute | |
| San Mateo, California, United States, 94401 | |
| Radiant Research-San Diego | |
| San Diego, California, United States, 92108 | |
| Radiant Research-San Diego | |
| San Diego, California, United States, 92108 | |
| United States, Florida | |
| Baptist Diabetes Associates | |
| Miami, Florida, United States, 33176 | |
| Internal Medicine Associates Department of Research | |
| Fort Myers, Florida, United States, 33901 | |
| Jacksonville Center for Clinical Research | |
| Jacksonville, Florida, United States, 32216 | |
| Metabolic Research Institute, Inc. | |
| West Palm Beach, Florida, United States, 33401 | |
| United States, Illinois | |
| Springfield Diabetes & Endocrine Center | |
| Springfield, Illinois, United States, 62704 | |
| United States, Maryland | |
| Frederick Primary Care Associates | |
| Frederick, Maryland, United States, 21702 | |
| United States, Missouri | |
| Radiant Research, Inc. | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Nevada | |
| Lovelace Scientific Resources, Inc. | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Hampshire | |
| Diabetes, Endocrine & Nutrition | |
| Hampton, New Hampshire, United States, 03842 | |
| United States, New Mexico | |
| Lovelace Scientific Resources | |
| Albuquerque, New Mexico, United States, 87108 | |
| United States, New York | |
| DOCS, Beth Israel Medical Center | |
| Yonkers, New York, United States, 10710 | |
| Great Lakes Medical Research | |
| Westfield, New York, United States, 14787 | |
| United States, North Carolina | |
| Piedmont Medical Research Associates | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Pennsylvania | |
| Jon Shapiro, MD | |
| Philadelphia, Pennsylvania, United States, 19146 | |
| United States, Tennessee | |
| Endocrinology Consultants of East Tennessee | |
| Knoxville, Tennessee, United States, 37909 | |
| United States, Texas | |
| Diabetes & Glandular Research Associates, P.A. | |
| San Antonio, Texas, United States, 78229 | |
| Israel Hartman, MD | |
| Arlington, Texas, United States, 76014 | |
| United States, Utah | |
| Jack Wahlen, MD | |
| Ogden, Utah, United States, 84403 | |
| United States, Washington | |
| Rainier Clinical Research Center, Inc. | |
| Renton, Washington, United States, 98055 | |
| Australia, New South Wales | |
| Clinical Trial and Research Unit | |
| Wollongong, New South Wales, Australia, 2500 | |
| Australian Clinical Research Centre | |
| Miranda, New South Wales, Australia, 2228 | |
| Royal North Shore Hospital | |
| St. Leonards, New South Wales, Australia, 2065 | |
| Australia, Queensland | |
| Royal Brisbane Hospital | |
| Brisbane, Queensland, Australia, 4029 | |
| Australia, South Australia | |
| Repatriation General Hospital | |
| Daw Park, South Australia, Australia, 5041 | |
| Royal Adelaid Hospital | |
| Adelaid, South Australia, Australia, 5000 | |
| SA Endocrine Clinical Research | |
| Keswick, South Australia, Australia, 5035 | |
| Australia, Victoria | |
| Eastern Health (Box Hill Hospital) | |
| Box Hill, Victoria, Australia, 3128 | |
| Royal Melbourne Hospital | |
| Parkville, Victoria, Australia, 3050 | |
| Australia, Western Australia | |
| Freemantle Hospital | |
| Freemantle, Western Australia, Australia | |
| Belgium | |
| Sint Niklaasstraat | |
| Sint Gillis Waas, Belgium, 9170 | |
| A.Z. Jan Palfijn | |
| Merksem, Belgium, 2170 | |
| CHU Sart Tilman | |
| Liege, Belgium, 4000 | |
| UZ Antwerpen | |
| Endegem, Belgium, 2650 | |
| UZ Gasthuisberg | |
| Leuven, Belgium, 3000 | |
| UZ Gent | |
| Gent, Belgium, 9000 | |
| Brazil | |
| Centro de Pesquisas em Diabetes e Doencas Endocrino Metabolicas/HUWC/UFC | |
| Fortaleza, Brazil, CE 60430-350 | |
| Centro Integrado de Diabetes e Hipertensao | |
| Fortaleza, Brazil, CE 601200-020 | |
| Hospital Nossa Senhora das Gracas | |
| Curitiba, Brazil, PR 80810-990 | |
| Santa Casa de Misericordia de Porto Alegre | |
| Porto Alegre, Brazil, RS 90020-090 | |
| Finland | |
| Eiran Sairaala c/o9 Clires | |
| Helsinki, Finland | |
| Oulu Deakoness Institution | |
| Oulu, Finland, 90100 | |
| Torikeskuksen Laakariasema, Yliopistonkatu | |
| Jyvaskyla, Finland | |
| Germany | |
| Diabetologische Schwerpunktpraxis | |
| Aschaffenburg, Germany, 63739 | |
| Diabetologische Schwerpunktpraxis | |
| Dortmund, Germany, 44137 | |
| Diabetologische Scherpunktpraxis | |
| Bosenheim, Germany, 55545 | |
| Diabetologische Schwerpunktpraxis | |
| Neuwied, Germany, 56564 | |
| IKFE GmbH | |
| Mainz, Germany | |
| Krankenhaus Bethanien | |
| Hamburg, Germany, 20251 | |
| Profil Institut fur Stoffwechselforschung GmbH | |
| Neuss, Germany | |
| Universitatskliniken des Saarlandes | |
| Homburg/Saar, Germany, 66421 | |
| Netherlands | |
| Diabetes Centrum Bilthoven | |
| Bilthoven, Netherlands, 3723 MB | |
| Atrium Medisch Centrum Brunssum | |
| Brunssum, Netherlands, 6422 BE | |
| Medisch Centrum | |
| Westeinde, Netherlands | |
| Refaja ziekenhuis | |
| Stadskanaal, Netherlands, 9501 HE | |
| Sint Antonius Ziekenhuis Nieuwegein | |
| Nieuwegein, Netherlands, 3435 CM | |
| Norway | |
| Betanien Spesialistsenter | |
| Oslo, Norway, 0172 | |
| Forskningsstiftelsen Hjertelaget | |
| Stravanger, Norway, 4011 | |
| Markeveien Spesialistpraksis | |
| Bergen, Norway, 5012 | |
| Spesiallegetjenesten AS | |
| Jessheim, Norway, 2050 | |
| Sykehuset Asker of Baerum HF | |
| Rud, Norway, 1309 | |
| Poland | |
| Oddzial Chorob Wewnetrznych | |
| Mielec, Poland, 39-300 | |
| Bydgoskie Centrum Diabetologii i Endokrynologii | |
| Bydgoszcz, Poland, 85-822 | |
| Wojewodzka Poradnia dla Chorych na Cukrzyce | |
| Warszawa, Poland, 03-242 | |
| Oddzial Chorob Wewnetrznych | |
| Czestochowa, Poland, 42-200 | |
| Oddzial Chorob Wewnetrznych i Diabetologii | |
| Warszawa, Poland, 02-507 | |
| Poradnia Diabetologiczna | |
| Lodz, Poland, Rzgowska 281/289 | |
| Poradnia Diabetologiczna | |
| Lublin, Poland, 20-718 | |
| NZOZ "Diab-Endo-Met" | |
| Krakow, Poland | |
| Portugal | |
| Associacao Protectora dos Diabeticos de Portugal | |
| Lisboa, Portugal, 1250-203 | |
| Associacao Protectora dos Diabeticos de Portugal | |
| Lisboa, Portugal, 1250-203 | |
| Centro Hospitalar de Coimbra | |
| Coimbra, Portugal, 3040-853 | |
| Hospital Garcia de Orta-Servico de Endocrinologia | |
| Almada, Portugal, 2805-267 | |
| Hospital Geral de Santo Antonio | |
| Porto, Portugal, 4099-001 | |
| Puerto Rico | |
| Dr. Luis Ruiz | |
| Ponce, Puerto Rico, 00733 | |
| Centro de Endocrinologia del Este | |
| Yabucoa, Puerto Rico, 00767 | |
| RCMI-Clinical Research Center | |
| Rio Piedras, Puerto Rico, 00935 | |
| RCMI-Clinical Research Center | |
| Rio Piedras, Puerto Rico, 00935 | |
| RCMI-Clinical Research Center | |
| Rio Piedras, Puerto Rico, 00935 | |
| Universidad Central del Caribe | |
| Bayamon, Puerto Rico, 00956 | |
| Hospital Alejandro Otero Lopez | |
| Manati, Puerto Rico, 00674 | |
| San Juan Health Center | |
| San Juan, Puerto Rico, 00936-3833 | |
| Spain | |
| Hospital Doce de Octubre | |
| Madrid, Spain, 28041 | |
| Hospital Gral de Mostoles | |
| Madrid, Spain, 28934 Mostoles | |
| Hospital la Ribera, Alzira | |
| Valencia, Spain, 46600 Alzira | |
| Hospital Vega Baja | |
| Alicante, Spain, 03300 | |
| Hospital Virgen de Valme | |
| Sevilla, Spain, 41014 | |
| Sweden | |
| Medicinska kliniken | |
| Helsingborg, Sweden, 251 87 | |
| Diabetesmottagningen, Intermedicinska kliniken | |
| Stockholm, Sweden, 118 83 | |
| Enheten for metabol kontroll | |
| Stockholm, Sweden, 171 76 | |
| Kliniska Forskningsenheren | |
| Lund, Sweden, 221 85 | |
| Lundberglaboratoriet for diabetesforskning | |
| Goteborg, Sweden, 413 45 | |
| CME, M71 | |
| Stockholm, Sweden, 141 86 | |
More Information
| Study ID Numbers: | H8O-MC-GWAA |
| Study First Received: | May 6, 2004 |
| Last Updated: | November 5, 2007 |
| ClinicalTrials.gov Identifier: | NCT00082381 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Diabetes Insulin glargine comparator Amylin Lilly |
|
Hypoglycemic Agents Metabolic Diseases Exenatide Physiological Effects of Drugs Diabetes Mellitus, Type 2 Glargine |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |