MAGE of Anagliptin Compared With Sitagliptin With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2021-01-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: JW Pharmaceutical
• Treatments: Anagliptin; Sitagliptin Phosphate

Criteria

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.