MAGE of Anagliptin Compared With Sitagliptin With Type 2 Diabetes Mellitus (ACACIA)

JW Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes

Treatments

Drug: Anagliptin BID Treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT04810507

JWP-GDL-404

Details and patient eligibility

About

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

Full description

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).

Enrollment

89 patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

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.