Primary Objective: To compare the clinical efficacy of gemigliptin and vildagliptin as add-on therapy to metformin in terms of change in Hemoglobin A1c (HbA1c) reduction. Secondary Objectives: To compare the safety and tolerability of gemigliptin and vildagliptin: * Number of patients who experience at least one episode of hypoglycemia. * Number of patients experiencing adverse event (AE), serious adverse event (SAE). * Assessment of patients compliance defined as number tablets returned by patients.
The study consists of 2 weeks screening and 24 weeks of treatment (a total of 26 weeks). The protocol includes a screening period of two weeks, after which they will be randomized to receive gemigliptin or vildagliptin. Patients will be evaluated through 4 mandatory visits during the study. Visit 1: Week -2 (screening) Visit 2: Week 0 (randomization) Visit 3: Week 12 (efficacy and safety evaluation) Visit 4: Week 24 (efficacy and safety evaluation)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
443
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
Investigational Site 03
Vladimir, Vladimirskaya Oblast’, Russia
Change from baseline in HbA1c
Time frame: Up to Week 24
Change from baseline in fasting plasma glucose
Time frame: Up to Week 24
Change from baseline in postprandial glucose
Time frame: Up to Week 24
Percentage of patients achieving HbA1c <7% and <6.5%
Time frame: Up to Week 24
Percentage of patients with at least one episode of hypoglycemia
Time frame: Up to Week 24
Number of episode of hypoglycemia (symptomatic, asymptomatic, severe hypoglycemia)
Time frame: Up to Week 24
Change from baseline in body weight
Time frame: Up to Week 24
Number of adverse events
Time frame: Up to Week 24
Number of serious adverse events
Time frame: Up to Week 24
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