MAGE of Anagliptin Compared With Sitagliptin With Type 2 Diabetes Mellitus

A Multi-center, Active Controlled, Randomized, Double-blinded, Parallel, Phase IV Study to Evaluate the Effect of Improving Glycemic Variability of Anagliptin Compared With Sitagliptin in Patients With Type 2 Diabetes Mellitus

An exploratory study to evaluate the Effect of Improving Glycemic Variability of Anagliptin Compared with Sitagliptin in Patients with Type 2 Diabetes Mellitus

This clinical trial is an exploratory study, and does not calculate the subject number based on statistical assumptions, and enrolls 50 subjects per group and a total of 100 subjects are registered to evaluate the effect of improving blood glucose variability in type 2 patients with anagliptin 100 mg twice a day(BID) and sitagliptin 100 mg once a day(QD).

Inclusion Criteria:

• Type 2 DM
• Metformin monotherapy for more than 8 weeks and metformin ≥ 1000 mg daily for more than 8 weeks.
• 6.5% ≤HbA1c< 8.5%
• Agreed Therapeutic Lifestyle change during the study period
• Obtained Informed Consent Form

Exclusion Criteria:

• Type 1 diabetes mellitus,
• History of intestinal obstruction
• NYHA class III to IV congestive heart failure,
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 X upper limit of normal (ULN) or Total bilirubin > 3 X ULN
• Creatinine clearance (CrCl)* < 50 mL/min
• Thyroid-stimulating hormone (TSH) ≥ 1.5 X ULN
• Allergic history for Anagliptin 또는 sitagliptin
• Being pregnant or nursing or suspected of being pregnant, or
• History of participation in other clinical studies in the preceding 3 months.