Glycemic Variability of Combination Therapies in T2DM
A multicenter study to evaluate efficacy and safety
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
178
5/500 mg, 5/1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID)
100 mg, for 12 weeks (PO, BID)
500 mg, 1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID)
The Catholic University of Korea, Bucheon St. Mary's Hospital, Principal Investigator
Seoul, South Korea
RECRUITINGMean change in Mean Amplitude of Glycemic Excursion (MAGE) from baseline to week 12
Time frame: Baseline to week 12
Change in the percentage of time spent within the target glucose range (70-180 mg/dL)
Time frame: Baseline to week 12
Change from baseline in mean blood glucose at 12 weeks
Time frame: Baseline to week 12
Change from baseline in HbA1c at 12 weeks
Time frame: Baseline to week 12
Change from baseline in FPG at 12 weeks
Time frame: Baseline to week 12
Change from baseline in HOMA-β at 12 weeks
HOMA- β: 20\*fasting insulin/\[(fasting plasma glucose\*0.0555)-3.5\]
Time frame: Baseline to week 12
Change from baseline in HOMA-IR at 12 weeks
HOMA-IR: fasting insulin\*(fasting glucose\*0.0555)/22.5
Time frame: Baseline to week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
10/5 mg, for 12 weeks (PO, QD)