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Clinical Trial Details

Trial ID: L6630
Source ID: NCT01457911
Associated Drug: Glimepiride And Metformin Hydrochloride Combination (Hoe490)
Title: Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Glimepiride and Metformin hydrochloride combination (HOE490)|DRUG: Glimepiride (HOE490)
Outcome Measures: Primary: Absolute change in HbA1c, 20 weeks, from baseline to week 20 | Secondary: Percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5%, respectively, 20 weeks, at week 20|Absolute change in Fasting Plasma Glucose, 20 weeks, from baseline to week 20|Number of patients reporting adverse events, 20 weeks, from baseline to week 20|Number of patients reporting serious adverse events, 20 weeks, from baseline to week 20|Hypoglycemia, 20 weeks, from baseline to week 20|Vital signs, 20 weeks, from baseline to week 20|Hematology, Serum chemistry and lipids, 20 weeks, from baseline to week 20
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 244
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-10
Completion Date: 2013-02
Results First Posted:
Last Update Posted: 2014-05-08
Locations: Investigational Site Number 156001, Beijing, 100044, China|Investigational Site Number 156016, Beijing, 100088, China|Investigational Site Number 156003, Beijing, 100730, China|Investigational Site Number 156018, Beijing, 100730, China|Investigational Site Number 156002, Beijing, 100853, China|Investigational Site Number 156019, Changchun, 130041, China|Investigational Site Number 156017, Chengdu, 610083, China|Investigational Site Number 156014, Guangzhou, 510080, China|Investigational Site Number 156022, Guangzhou, 510150, China|Investigational Site Number 156011, Hangzhou, 310003, China|Investigational Site Number 156012, Hefei, 230001, China|Investigational Site Number 156020, Jinan, 250012, China|Investigational Site Number 156023, Jinan, 250021, China|Investigational Site Number 156010, Shanghai, 200040, China|Investigational Site Number 156006, Shanghai, 200072, China|Investigational Site Number 156009, Shanghai, 200080, China|Investigational Site Number 156021, Shenyang, 110022, China|Investigational Site Number 156005, Shijiazhuang, 050051, China|Investigational Site Number 156004, Taiyuan, 030001, China|Investigational Site Number 156024, Tianjin, 300052, China|Investigational Site Number 156008, Wuhan, 430022, China|Investigational Site Number 156015, Xiamen, 361003, China
URL: https://clinicaltrials.gov/show/NCT01457911

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress