Primary Objective: -To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of HbA1c reduction, during 24-week treatment period in patients with inadequately controlled type 2 diabetes mellitus. Secondary Objective: To assess the effects of the fixed combination of glimepiride and metformin at week 24 on: * Percentage of patients reaching HbA1c \<7% * Percentage of patients reaching HbA1c \<6.5%. * Fasting Plasma Glucose (FPG) * Safety and tolerability
The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period and 3 days follow-up period with a last call phone visit.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
167
Pharmaceutical form:tablet Route of administration: oral
Investigational Site Number 422-002
Beirut, Lebanon
Investigational Site Number 422-001
Hazmiyeh, Lebanon
Investigational Site Number 643-03
Saint Petersburg, Russia
Change in HbA1c
Time frame: from baseline to week 24
Percentage of patients with HbA1c < 7%
Time frame: at week 24
Percentage of patients with HbA1c < 6.5%
Time frame: at week 24
Change in Fasting Plasma Glucose (FPG)
Time frame: from baseline to week 24
Number of patients with adverse events
Time frame: over the 24-week treatment period
Hypoglycemia
Time frame: over the 24-week treatment period
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Investigational Site Number 643002
Saint Petersburg, Russia
Investigational Site Number 643001
Samara, Russia
Investigational Site Number 804003
Chernivtsi, Ukraine
Investigational Site Number 804008
Donetsk, Ukraine
Investigational Site Number 804004
Donetsk, Ukraine
Investigational Site Number 804001
Donetsk, Ukraine
Investigational Site Number 804010
Odesa, Ukraine
...and 3 more locations