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| Sponsor: | Amylin Pharmaceuticals, Inc. |
|---|---|
| Collaborator: |
Eli Lilly and Company |
| Information provided by: | Amylin Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00082407 |
Purpose
This is a Phase 3, multicenter, open-label, comparator-controlled 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: | Efficacy of Exenatide (AC2993, Synthetic Exendin-4, LY2148568) Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using 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| Croatia | |
| Klinicki bolnicki centar Zagreb-Rebro | |
| Zagreb, Croatia, 10000 | |
| Klinica bolnica Dubrava | |
| Zagreb, Croatia, 10000 | |
| Clinical Hospital Osijek | |
| Osijek, Croatia, 31000 | |
| Opca bolnica "Sveti Duh" | |
| Zagreb, Croatia, 10000 | |
| Germany | |
| Dr. Thomas Behnke | |
| Neuwied, Germany, 56564 | |
| Dr. Klaus Busch | |
| Dortmund, Germany, 44137 | |
| Internistische Gemeinschaftspraxis | |
| Augsburg, Germany, 86150 | |
| Dr. Bernd Donaubauer | |
| Oschatz, Germany, 04758 | |
| Dr. Joerg Steindorf | |
| Schkeuditz, Germany, 04435 | |
| Institut for diabetic research | |
| Munich, Germany, 80804 | |
| Dr. Karlheinz Hehemann | |
| Beckum, Germany, 59269 | |
| Dr. Jerzi Jasinski | |
| Wiesbaden, Germany, 65183 | |
| Medical Clinic and Policlinic 3 | |
| Giessen, Germany, 35392 | |
| Diabetologische Schwerpunktpraxis | |
| Hamburg, Germany, 21073 | |
| Marienhospital Osnabruck | |
| Osnabruck, Germany, 49074 | |
| Profil, Institut fur Stoffwechselstorungen | |
| Neuss, Germany, 41460 | |
| IKFE GmbH | |
| Mainz, Germany, 55119 | |
| Greece | |
| "Polyclinic" General Hospital of Athens | |
| Athens, Greece, 10552 | |
| Diabetes Center | |
| Athens, Greece, 11527 | |
| 1st Internal Medicine Department "Papagergiou" | |
| Thessaloniki, Greece, 56429 | |
| Department of Endocrinology | |
| Athens, Greece, 10676 | |
| University Hospital of Patras | |
| Patras, Greece, 26500 | |
| Italy | |
| Instituto di Endocrinologia | |
| Catania, Italy, 95124 | |
| Policlinico Univarsitario P. Giaccone | |
| Palermo, Italy, 90127 | |
| Dipartimento di fisiopatologia clinica | |
| Florence, Italy, 50134 | |
| U.O. Medicina Generale | |
| Milan, Italy, 60-20132 | |
| Ospedale Civile di Padova | |
| Padova, Italy, 35128 | |
| U.O. Universita di Malattie del Metabolismo e Diabetologia | |
| Torino, Italy | |
| Netherlands | |
| Rijnstate Ziekenhuis | |
| Arnhem, Netherlands, 6815 AD | |
| Maxima Medisch Centrum Location Eindhoven | |
| Eindhoven, Netherlands, 5631 BM | |
| Gelre Ziekenhuizen | |
| Apeldoorn, Netherlands, 7300 DS | |
| Portugal | |
| Hospital de Santo Andre | |
| Leiria, Portugal, 2410-197 | |
| Hospitais da Universidade de Coimbra | |
| Coimbra, Portugal, 3000-076 | |
| Hospital Pedro Hispano | |
| Matosinhos, Portugal, 4454-509 | |
| Associacao Protectora dos Diabeticos de Portugal | |
| Lisboa, Portugal, 1250-203 | |
| Romania | |
| Spitalul Judetean Brasov | |
| Brasov, Romania, 500326 | |
| Institutul de Diabet | |
| Bucuresti, Romania, 020475 | |
| Institutul de Diabet | |
| Bucuresti, Romania, 020475 | |
| Spitalul Clinic nr. 1 Judetean | |
| Judet Timis, Romania, 300723 | |
| Russian Federation | |
| National Endocrinology Research Center | |
| Moscow, Russian Federation, 117036 | |
| Medical Military Academy | |
| St. Petersburg, Russian Federation, 198013 | |
| Moscow State Medical Stomatological | |
| Moscow, Russian Federation, 123448 | |
| National Endocrinology Research Center | |
| Moscow, Russian Federation, 117036 | |
| Setchenov Moscow Medical Academy | |
| Moscow, Russian Federation, 119881 | |
| Hospital of St. Elizabeth's | |
| St. Petersburg, Russian Federation, 193257 | |
| City Clinical Hospital #2 | |
| St. Petersburg, Russian Federation, 194354 | |
| Russian Medical Academy for Advanced Medical Studies, Ministry of Health | |
| Moscow, Russian Federation, 125315 | |
| Slovenia | |
| Splosna bolnisnica Maribor | |
| Maribor, Slovenia, 2000 | |
| Univerzitetni klinicni center Ljubljana | |
| Ljubljana, Slovenia, 1000 | |
| Spain | |
| Endocrinology Service (Planta Baja) | |
| Palma de Mallorca, Spain, 07198 | |
| Hospital Virgen de Valme | |
| Sevilla, Spain, 41014 | |
| Hospital Clinic i Provincial de Barcelona | |
| Barcelona, Spain, 08036 | |
| Hospital General de Teruel | |
| Teruel, Spain, 44002 | |
| Hospital Vega Baja | |
| Alicante, Spain, 03300 | |
| Hospital la Ribera Alzira | |
| Valencia, Spain, 46600 Alzira | |
| Taiwan | |
| Veteran General Hospital-Taichung | |
| Taichung, Taiwan, 407 | |
| Tzu Chi General Hospital | |
| Hualien, Taiwan | |
| Changhua Christian Hospital | |
| Changhua, Taiwan, 500 | |
| Tri-Service General Hospital | |
| Taipei, Taiwan | |
| United Kingdom | |
| The Michael White Center for Diabetes and Endocrinology | |
| Hull, United Kingdom, HU3 2JZ | |
| Diabetes Research, Ward 34, Birmingham Heartlands Hospital | |
| Birmingham, United Kingdom, B9 5SS | |
| Colchester General Hospital | |
| Colchester, United Kingdom, CO4 5JL | |
| Wellcome Labs, Royal Victoria Infirmary | |
| Newcastle upon Tyne, United Kingdom, NE1 4LP | |
| Royal Infirmary of Edinburgh | |
| Edinburgh, United Kingdom, EH3 9YW | |
| Diabetes Unit, Gladsone Centre, Maelor Hospital | |
| Wrexham, United Kingdom, LL13 7TD | |
| Diabetes Trial Unit OCDEM, Churchill Hospital | |
| Oxford, United Kingdom, OX3 7LJ | |
| Diabetes Unit, Blackburn Royal Infirmary | |
| Blackburn, United Kingdom, BB2 3LR | |
| Education Centre, James Cook University Hospital | |
| Middlesbrough, United Kingdom, TS4 3BW | |
| Queens Medical Centre | |
| Nottingham, United Kingdom, NG7 2UH | |
| Clinical Sciences Centre | |
| Liverpool, United Kingdom, L7 8XP | |
| Glasgow Royal Infirmary | |
| Glasgow, United Kingdom, G4 0SF | |
More Information
| Study ID Numbers: | H8O-MC-GWAD |
| Study First Received: | May 6, 2004 |
| Last Updated: | November 5, 2007 |
| ClinicalTrials.gov Identifier: | NCT00082407 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
diabetes exendin Amylin Lilly insulin aspart |
|
Hypoglycemic Agents Metabolic Diseases Exenatide Physiological Effects of Drugs Diabetes Mellitus, Type 2 Insulin, Asp(B28)- |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |