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Clinical Trial Details

Trial ID: L3288
Source ID: NCT01121835
Associated Drug: Insulin Glargine
Title: Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study
Acronym: GALAPAGOS
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: INSULIN GLARGINE|DRUG: INSULIN GLULISINE|DRUG: PREMIXED INSULIN
Outcome Measures: Primary: Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) ≤ 56 mg/dL [3.1 mmol/L], From baseline (visit 2, week 0) to visit 14 (week 24) | Secondary: 7-point plasma glucose (PG) profile recorded on 3 consecutive days, From baseline (visit 2, week 0) to visit 14 (week 24)|Self-monitored PG (Plasma Glucose) values over 3 consecutive days, before visit 4 (week 2)|Self-monitored PG (Plasma Glucose) values over 3 consecutive days, before visit 8 (week 6)|Self-monitored PG (Plasma Glucose) values over 3 consecutive days, before visit 12 (week 16)|Weight and supine blood pressure, From baseline (visit 2, week 0) to visit 14 (week 24)|Insulin doses of the day before each visit, from visit 3 (week 1) to visit 14 (week 24)|Biochemistry and lipid profile, From baseline (visit 2, week 0) to visit 14 (week 24)
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 934
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-02
Completion Date: 2012-03
Results First Posted:
Last Update Posted: 2013-04-04
Locations: Investigational Site Number 040-004, Sankt Stefan, A-8511, Austria|Investigational Site Number 040-002, Vienna, A-1030, Austria|Investigational Site Number 040-001, Vienna, Austria|Investigational Site Number 040-003, Vienna, Austria|Investigational Site Number 076002, Belém, 66073-000, Brazil|Investigational Site Number 076005, Curitiba, 80060-900, Brazil|Investigational Site Number 076004, Fortaleza, 60430-370, Brazil|Investigational Site Number 076001, Porto Alegre, 90035-001, Brazil|Investigational Site Number 076003, São Paulo, 04024-002, Brazil|Investigational Site Number 156004, Beijing, China|Investigational Site Number 156005, Beijing, China|Investigational Site Number 156006, Beijing, China|Investigational Site Number 156011, Chongqing, China|Investigational Site Number 156009, Dalian, China|Investigational Site Number 156008, Guangzhou, China|Investigational Site Number 156012, Haikou, China|Investigational Site Number 156007, Nanjing, China|Investigational Site Number 156001, Shanghai, China|Investigational Site Number 156002, Shanghai, China|Investigational Site Number 156003, Shanghai, China|Investigational Site Number 156010, Shenyang, China|Investigational Site Number 170001, Bogota, Colombia|Investigational Site Number 170002, Bogota, Colombia|Investigational Site Number 170003, Bucaramanga, Colombia|Investigational Site Number 170005, Manizales, 170, Colombia|Investigational Site Number 170004, Pereira, 170, Colombia|Investigational Site Number 208-001, Hvidovre, 2650, Denmark|Investigational Site Number 208-003, København NV., 2400, Denmark|Investigational Site Number 208-002, København S., 2300, Denmark|Investigational Site Number 300006, Alexandroupolis, 68100, Greece|Investigational Site Number 300001, Athens, Greece|Investigational Site Number 300002, Athens, Greece|Investigational Site Number 300003, Athens, Greece|Investigational Site Number 300004, Athens, Greece|Investigational Site Number 300005, Iraklion, 71001, Greece|Investigational Site Number 300011, Maroussi, Athens, 15123, Greece|Investigational Site Number 300008, Thessaloniki, 546 36, Greece|Investigational Site Number 300010, Thessaloniki, 56429, Greece|Investigational Site Number 300007, Thessaloniki, 57010, Greece|Investigational Site Number 356008, Bangalore, 560043, India|Investigational Site Number 356003, Bangalore, 560052, India|Investigational Site Number 356007, Bangalore, 560092, India|Investigational Site Number 356006, Bhubaneshwar, 751019, India|Investigational Site Number 356001, Hyderabad, 500034, India|Investigational Site Number 356005, Hyderabad, 500034, India|Investigational Site Number 356004, Trivandrum, India|Investigational Site Number 380-010, Catania, 95122, Italy|Investigational Site Number 380-008, Catania, 95124, Italy|Investigational Site Number 380-006, Colleferro, 00034, Italy|Investigational Site Number 380-007, Foggia, 71100, Italy|Investigational Site Number 380-005, Forlì, Italy|Investigational Site Number 380-001, Genova, 16132, Italy|Investigational Site Number 380-011, Merano, 39100, Italy|Investigational Site Number 380-009, Napoli, 80131, Italy|Investigational Site Number 380-012, Napoli, 80131, Italy|Investigational Site Number 380-004, Parma, 43100, Italy|Investigational Site Number 410004, Ansan-si, Kyouggi-do, Korea, Republic of|Investigational Site Number 410003, Koyang-si, Korea, Republic of|Investigational Site Number 410001, Seoul, Korea, Republic of|Investigational Site Number 410002, Seoul, Korea, Republic of|Investigational Site Number 001, Kuwait, Kuwait|Investigational Site Number 484004, Aguascalientes, 20020, Mexico|Investigational Site Number 484001, Aguascalientes, 20230, Mexico|Investigational Site Number 484003, Guadalajara, 44650, Mexico|Investigational Site Number 484002, Guadalajara, 44680, Mexico|Investigational Site Number 484005, Puebla, 72000, Mexico|Investigational Site Number 642001, Iasi, 700111, Romania|Investigational Site Number 642002, Iasi, Romania|Investigational Site Number 642003, Oradea, 410169, Romania|Investigational Site Number 724001, Avila, 05071, Spain|Investigational Site Number 724002, Barcelona, 08022, Spain|Investigational Site Number 724008, Galdakao, 48960, Spain|Investigational Site Number 724007, Lugo, 27004, Spain|Investigational Site Number 724004, Madrid, 28805, Spain|Investigational Site Number 724009, Pamplona, 31008, Spain|Investigational Site Number 724005, Santa Coloma de Gramanet, 8923, Spain|Investigational Site Number 724003, Sevilla, 41010, Spain|Investigational Site Number 724006, Valencia, 46010, Spain|Investigational Site Number 158004, Changhua County, Taiwan|Investigational Site Number 158003, Hsintien, 23137, Taiwan|Investigational Site Number 158007, Kaohsiung Hsien,, Taiwan|Investigational Site Number 158006, New Taipei city, Taiwan|Investigational Site Number 158009, Taichung City, Taiwan|Investigational Site Number 158001, Taichung, 407, Taiwan|Investigational Site Number 158005, Tainan, Taiwan|Investigational Site Number 158002, Taipei, Taiwan|Investigational Site Number 792-013, Ankara, 06100, Turkey|Investigational Site Number 792-009, Canakkale, 17110, Turkey|Investigational Site Number 792-006, Diyarbakir, 21830, Turkey|Investigational Site Number 792-004, Istanbul, 34098, Turkey|Investigational Site Number 792-001, Izmir, 35340, Turkey|Investigational Site Number 792-016, Konya, Turkey|Investigational Site Number 792-007, Sivas, 58140, Turkey|Investigational Site Number 792-005, Trabzon, Turkey|Investigational Site Number 792-002, Van, 65080, Turkey|Investigational Site Number 784-001, Dubai, United Arab Emirates
URL: https://clinicaltrials.gov/show/NCT01121835

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress