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Clinical Trial Details

Trial ID: L5994
Source ID: NCT01699932
Associated Drug: Glimepiride+Metformin (Amaryl M®) - Hoe4900
Title: Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled
Acronym: LEGEND
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Glimepiride+metformin (Amaryl M®) - HOE4900
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 to week 24|Number of patients with adverse events, over the 24-week treatment period|Hypoglycemia, over the 24-week treatment period
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 167
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-09
Completion Date: 2014-04
Results First Posted:
Last Update Posted: 2014-05-08
Locations: Investigational Site Number 422-002, Beirut, Lebanon|Investigational Site Number 422-001, Hazmieh, Lebanon|Investigational Site Number 643001, Samara, Russian Federation|Investigational Site Number 643002, St-Petersburg, Russian Federation|Investigational Site Number 643-03, St.-Petersburg, Russian Federation|Investigational Site Number 804003, Chernivtsi, 58022, Ukraine|Investigational Site Number 804008, Donetsk, 83003, Ukraine|Investigational Site Number 804004, Donetsk, 83059, Ukraine|Investigational Site Number 804001, Donetsk, 83099, Ukraine|Investigational Site Number 804010, Odessa, Ukraine|Investigational Site Number 804006, Poltava, 36011, Ukraine|Investigational Site Number 804007, Vinnytsya, 21010, Ukraine|Investigational Site Number 804002, Vinnytsya, 21029, Ukraine
URL: https://clinicaltrials.gov/show/NCT01699932

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