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Clinical Trial Details

Trial ID: L4429
Source ID: NCT01495013
Associated Drug: 1mg Glimepiride/10mg Atorvastatin Fdc
Title: A Comparison of Atorvastatin and Glimepiride Fixed Dose Combination and Atorvastatin and Glimepiride Loose Combination in the Treatment of Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: 1mg Glimepiride/10mg Atorvastatin FDC|DRUG: 2mg Glimepiride/10mg Atorvastatin FDC|DRUG: 3mg Glimepiride/10mg Atorvastatin FDC|DRUG: 4mg Glimepiride/10mg Atorvastatin FDC|DRUG: 1mg Glimepiride/20mg Atorvastatin FDC|DRUG: 2mg Glimepiride/20mg Atorvastatin FDC|DRUG: 3mg Glimepiride/20mg Atorvastatin FDC|DRUG: 4mg Glimepiride/20mg Atorvastatin FDC|DRUG: 1mg Glimepiride|DRUG: 2mg Glimepiride|DRUG: 3mg Glimepiride|DRUG: 4mg Glimepiride|DRUG: 10mg Atorvastatin|DRUG: 20mg Atorvastatin
Outcome Measures: Primary: Non inferiority of glimepiride/atorvastatin compared with glimepiride + atorvastatin taken as separate tablets in reducing HbA1c levels, Change from baseline, Week 20|Non inferiority of glimepiride/atorvastatin compared with glimepiride + atorvastatin taken as separate tablets in reducing LDL levels, Change from baseline, Week 20 |
Sponsor/Collaborators: Sponsor: GlaxoSmithKline
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 427
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-12
Completion Date: 2013-09
Results First Posted:
Last Update Posted: 2016-11-21
Locations: GSK Investigational Site, Bucheon, 134 727, Korea, Republic of|GSK Investigational Site, Busan, 602-739, Korea, Republic of|GSK Investigational Site, Kangwondo, 220-701, Korea, Republic of|GSK Investigational Site, Seocho-ku, Seoul, 137-701, Korea, Republic of|GSK Investigational Site, Seongnam-si Gyeonggi-do, 463-707, Korea, Republic of|GSK Investigational Site, Seoul, 110-744, Korea, Republic of|GSK Investigational Site, Seoul, 110-746, Korea, Republic of|GSK Investigational Site, Seoul, 135-710, Korea, Republic of|GSK Investigational Site, Seoul, 138-736, Korea, Republic of|GSK Investigational Site, Seoul, 139-872, Korea, Republic of|GSK Investigational Site, Seoul, 152-703, Korea, Republic of|GSK Investigational Site, Suwon, 463442, Korea, Republic of|GSK Investigational Site, Ipoh, 30450, Malaysia|GSK Investigational Site, Johor Bahru, 80100, Malaysia|GSK Investigational Site, Kuala Lumpur, 59100, Malaysia|GSK Investigational Site, Kubang Kerian, 16150, Malaysia|GSK Investigational Site, Cuernavaca, 62250, Mexico|GSK Investigational Site, Del. Cuauhtémoc, 06700, Mexico|GSK Investigational Site, Gadalajara, Jalisco, C.P. 44130, Mexico|GSK Investigational Site, Guadalajara Jalisco, C.P. 44210, Mexico|GSK Investigational Site, Mexico City, 06700, Mexico|GSK Investigational Site, Mexico, D.F., 11650, Mexico|GSK Investigational Site, Cebu City, 6000, Philippines|GSK Investigational Site, Davao City, 8000, Philippines|GSK Investigational Site, Manila, 1008, Philippines|GSK Investigational Site, Pasig City, 1600, Philippines|GSK Investigational Site, Sta. Cruz, Manila, 1012, Philippines|GSK Investigational Site, Moscow, 109240, Russian Federation|GSK Investigational Site, Saratov, 410054, Russian Federation|GSK Investigational Site, St. Petersburg, 191119, Russian Federation|GSK Investigational Site, Chiangrai, 57000, Thailand|GSK Investigational Site, Nakhon Ratchasima, 30000, Thailand|GSK Investigational Site, Rajathevee, 10400, Thailand
URL: https://clinicaltrials.gov/show/NCT01495013

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D320 Atorvastatin small molecule DB01076 Details