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Clinical Trial Details

Trial ID: L6307
Source ID: NCT01459809
Associated Drug: Glimepiride
Title: Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients
Acronym: RECOMMEND
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: GLIMEPIRIDE|DRUG: METFORMIN
Outcome Measures: Primary: Change in HbA1c, from baseline to week 24 | Secondary: Percentage of patients with HbA1c < 7%, at week 24|Percentage of patients with HbA1c < 6.5 %, at week 24|Change in Fasting Plasma Glucose (FPG), from baseline week 24|Number of patients reporting adverse events, overt the 24-weeks treatment period|Frequence and incidence of hypoglycemia, over the 24-weeks treatment period
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 538
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-02
Completion Date: 2014-01
Results First Posted:
Last Update Posted: 2015-01-21
Locations: Investigational Site Number 01206, Algeries, Algeria|Investigational Site Number 01203, Oran, 31000, Algeria|Investigational Site Number 01205, Setif, 19000, Algeria|Investigational Site Number 17003, El Espinal, Colombia|Investigational Site Number 170001, Manizales, 170, Colombia|Investigational Site Number 81801, Cairo, Egypt|Investigational Site Number 81802, Cairo, Egypt|Investigational Site Number 81803, Cairo, Egypt|Investigational Site Number 32001, Guatemala, Guatemala|Investigational Site Number 32002, Guatemala, Guatemala|Investigational Site Number 32003, Guatemala, Guatemala|Investigational Site Number 32004, Guatemala, Guatemala|Investigational Site Number 356001, Bangalore, 560043, India|Investigational Site Number 356002, Bangalore, 560052, India|Investigational Site Number 356006, Ernakulam, India|Investigational Site Number 356003, Indore, 452010, India|Investigational Site Number 356009, Lucknow, 226003, India|Investigational Site Number 356010, Mumbai, India|Investigational Site Number 356007, Nashik, 422002, India|Investigational Site Number 356008, Pune, 411007, India|Investigational Site Number 356005, Varanasi, India|Investigational Site Number 364001, Tehran, 1411413137, Iran, Islamic Republic of|Investigational Site Number 364002, Tehran, 1666694516, Iran, Islamic Republic of|Investigational Site Number 36403, Tehran, Iran, Islamic Republic of|Investigational Site Number 42201, Beirut, Lebanon|Investigational Site Number 42202, Beirut, Lebanon|Investigational Site Number 42203, Chouf, Lebanon|Investigational Site Number 422004, Hazmieh, Lebanon|Investigational Site Number 484002, Guadalajara, 44340, Mexico|Investigational Site Number 484003, Guadalajara, 44670, Mexico|Investigational Site Number 643003, Moscow, 119002, Russian Federation|Investigational Site Number 643002, Saratov, 410012, Russian Federation|Investigational Site Number 643001, St.-Petersburg, Russian Federation|Investigational Site Number 710-002, Durban, 4091, South Africa|Investigational Site Number 710-001, Durban, 4092, South Africa|Investigational Site Number 78803, La Marsa, 2070, Tunisia|Investigational Site Number 78804, La Marsa, 2070, Tunisia|Investigational Site Number 78805, Sfax, Tunisia|Investigational Site Number 78801, Tunis, Tunisia|Investigational Site Number 78802, Tunis, Tunisia|Investigational Site Number 78806, Tunis, Tunisia|Investigational Site Number 78807, Tunis, Tunisia|Investigational Site Number 792-004, Adana, Turkey|Investigational Site Number 792-003, Antalya, 07070, Turkey|Investigational Site Number 792-001, Istanbul, 34722, Turkey|Investigational Site Number 792-006, Istanbul, 34890, Turkey|Investigational Site Number 792-002, Kutahya, Turkey|Investigational Site Number 792-005, Sivas, 58140, Turkey|Investigational Site Number 804001, Kyiv, 02175, Ukraine|Investigational Site Number 804002, Kyiv, 04114, Ukraine|Investigational Site Number 804003, Zaporozhye, Ukraine|Investigational Site Number 784-001, Dubai, United Arab Emirates|Investigational Site Number 784-002, Dubai, United Arab Emirates|Investigational Site Number 784-003, Dubai, United Arab Emirates|Investigational Site Number 784-004, Sharjah, 46458, United Arab Emirates
URL: https://clinicaltrials.gov/show/NCT01459809

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details