Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6269
Source ID: NCT00082407
Associated Drug: Exenatide
Title: Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00082407/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: exenatide|DRUG: biphasic insulin aspart
Outcome Measures: Primary: Change in Glcosylated Hemoglobin (HbA1c), Change in HbA1c from baseline to week 52, baseline, week 52 | 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 52 (percentage = \[number of subjects with HbA1c \<=7% at week 52 divided by number of subjects with HbA1c \>7% at baseline\] \* 100%)., 52 weeks|Change in Body Weight, Change in body weight from baseline to week 52., baseline, week 52|Change in Fasting Serum Glucose, Change in fasting serum glucose from baseline to week 52, baseline, week 52|Change in 7-point Self-monitored Blood Glucose (SMBG) Profile, Change in 7-point (pre-breakfast, after breakfast, pre-lunch, after lunch, pre-dinner, after dinner, 0300 hours) SMBG profile from baseline to week 52, baseline, week 52|Percentage of Patients With Hypoglycemic Events, Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 52 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 52 week Parent Study divided by the total number of patients who particiapted in the 52 week Parent Study, 52 weeks|Change in Rate of Hypoglycemic Events, Change in rate of hypoglycemic events per 30 days per patient from baseline to week 52, baseline, week 52
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 505
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2003-11
Completion Date: 2008-07
Results First Posted: 2013-07-31
Last Update Posted: 2015-04-07
Locations: Clinical Hospital Osijek, Osijek, 31000, Croatia|Klinica bolnica Dubrava, Zagreb, 10000, Croatia|Klinicki bolnicki centar Zagreb-Rebro, Zagreb, 10000, Croatia|Opca bolnica "Sveti Duh", Zagreb, 10000, Croatia|Internistische Gemeinschaftspraxis, Augsburg, 86150, Germany|Dr. Karlheinz Hehemann, Beckum, 59269, Germany|Dr. Klaus Busch, Dortmund, 44137, Germany|Medical Clinic and Policlinic 3, Giessen, 35392, Germany|Diabetologische Schwerpunktpraxis, Hamburg, 21073, Germany|IKFE GmbH, Mainz, 55119, Germany|Institut for diabetic research, Munich, 80804, Germany|Profil, Institut fur Stoffwechselstorungen, Neuss, 41460, Germany|Dr. Thomas Behnke, Neuwied, 56564, Germany|Dr. Bernd Donaubauer, Oschatz, 04758, Germany|Marienhospital Osnabruck, Osnabruck, 49074, Germany|Dr. Joerg Steindorf, Schkeuditz, 04435, Germany|Dr. Jerzi Jasinski, Wiesbaden, 65183, Germany|"Polyclinic" General Hospital of Athens, Athens, 10552, Greece|Department of Endocrinology, Athens, 10676, Greece|Diabetes Center, Athens, 11527, Greece|University Hospital of Patras, Patras, 26500, Greece|1st Internal Medicine Department "Papagergiou", Thessaloniki, 56429, Greece|Instituto di Endocrinologia, Catania, 95124, Italy|Dipartimento di fisiopatologia clinica, Florence, 50134, Italy|U.O. Medicina Generale, Milan, 60-20132, Italy|Ospedale Civile di Padova, Padova, 35128, Italy|Policlinico Univarsitario P. Giaccone, Palermo, 90127, Italy|U.O. Universita di Malattie del Metabolismo e Diabetologia, Torino, Italy|Gelre Ziekenhuizen, Apeldoorn, 7300 DS, Netherlands|Rijnstate Ziekenhuis, Arnhem, 6815 AD, Netherlands|Maxima Medisch Centrum Location Eindhoven, Eindhoven, 5631 BM, Netherlands|Hospitais da Universidade de Coimbra, Coimbra, 3000-076, Portugal|Hospital de Santo Andre, Leiria, 2410-197, Portugal|Associacao Protectora dos Diabeticos de Portugal, Lisboa, 1250-203, Portugal|Hospital Pedro Hispano, Matosinhos, 4454-509, Portugal|Spitalul Judetean Brasov, Brasov, 500326, Romania|Institutul de Diabet, Bucuresti, 020475, Romania|Spitalul Clinic nr. 1 Judetean, Judet Timis, 300723, Romania|National Endocrinology Research Center, Moscow, 117036, Russian Federation|Setchenov Moscow Medical Academy, Moscow, 119881, Russian Federation|Moscow State Medical Stomatological, Moscow, 123448, Russian Federation|Russian Medical Academy for Advanced Medical Studies, Ministry of Health, Moscow, 125315, Russian Federation|Hospital of St. Elizabeth's, St. Petersburg, 193257, Russian Federation|City Clinical Hospital #2, St. Petersburg, 194354, Russian Federation|Medical Military Academy, St. Petersburg, 198013, Russian Federation|Univerzitetni klinicni center Ljubljana, Ljubljana, 1000, Slovenia|Splosna bolnisnica Maribor, Maribor, 2000, Slovenia|Hospital Vega Baja, Alicante, 03300, Spain|Hospital Clinic i Provincial de Barcelona, Barcelona, 08036, Spain|Endocrinology Service (Planta Baja), Palma de Mallorca, 07198, Spain|Hospital Virgen de Valme, Sevilla, 41014, Spain|Hospital General de Teruel, Teruel, 44002, Spain|Hospital la Ribera Alzira, Valencia, 46600 Alzira, Spain|Changhua Christian Hospital, Changhua, 500, Taiwan|Tzu Chi General Hospital, Hualien, Taiwan|Veteran General Hospital-Taichung, Taichung, 407, Taiwan|Tri-Service General Hospital, Taipei, Taiwan|Diabetes Research, Ward 34, Birmingham Heartlands Hospital, Birmingham, B9 5SS, United Kingdom|Diabetes Unit, Blackburn Royal Infirmary, Blackburn, BB2 3LR, United Kingdom|Colchester General Hospital, Colchester, CO4 5JL, United Kingdom|Royal Infirmary of Edinburgh, Edinburgh, EH3 9YW, United Kingdom|Glasgow Royal Infirmary, Glasgow, G4 0SF, United Kingdom|The Michael White Center for Diabetes and Endocrinology, Hull, HU3 2JZ, United Kingdom|Clinical Sciences Centre, Liverpool, L7 8XP, United Kingdom|Education Centre, James Cook University Hospital, Middlesbrough, TS4 3BW, United Kingdom|Wellcome Labs, Royal Victoria Infirmary, Newcastle upon Tyne, NE1 4LP, United Kingdom|Queens Medical Centre, Nottingham, NG7 2UH, United Kingdom|Diabetes Trial Unit OCDEM, Churchill Hospital, Oxford, OX3 7LJ, United Kingdom|Diabetes Unit, Gladsone Centre, Maelor Hospital, Wrexham, LL13 7TD, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00082407

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress