Study subjects will be randomly assigned to the three groups and receive the study drug for maximum of 156 weeks and undergo blood samplings and other diabetes mellitus-related tests. The aim of the present study is to evaluate the durability of glycemic control over 3 years for patients with type 2 diabetes on diet and exercise therapy treated with oral hypoglycemic drug monotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
567
Imeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily).
Metformin 500 mg orally twice daily in the morning and evening (1000 mg daily). However, until 2 weeks after the start of treatment, 250 mg should be administered orally twice daily in the morning and evening. Thereafter, after 4, 8, or 12 weeks, the dose may be increased up to 750 mg twice daily (1500 mg daily) if the physician determines that the hypoglycemic effect is inadequate.
Vildagliptin 50 mg orally twice daily in the morning and evening (100 mg daily).
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku, Tokyo, Japan
RECRUITINGTime from study drug initiation (Week 0) to detection of two consecutive HbA1c levels of 7.0% or higher by laboratory tests after Week 16.
Time frame: From 16 to 156 weeks after the start of study drug administration
Time from Week 0 to addition of a type 2 diabetes mellitus medication after Week 16
Time frame: From 16 to 156 weeks after the start of study drug administration
Time from detection of two consecutive HbA1c levels of 7.0% or higher to addition of a type 2 diabetes mellitus medication after Week 16.
Time frame: From 16 to 156 weeks after the start of study drug administration
HbA1c level, fasting blood glucose level, and their changes from baseline at each measurement point
Time frame: From 0 to 156 weeks after the start of study drug administration
Maximum decrease in HbA1c level during the observation period
Time frame: From 0 to 156 weeks after the start of study drug administration
Proportion of patients achieving HbA1c level less than 7.0% at each measurement point
Time frame: From 0 to 156 weeks after the start of study drug administration
Number of times of achieving HbA1c level less than 7.0% during the observation period
Time frame: From 0 to 156 weeks after the start of study drug administration
Time from Week 0 to detection of two consecutive HbA1c levels of 7.0% or higher by laboratory tests after Week 16 by patient characteristics
Time frame: From 0 to 156 weeks after the start of study drug administration
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