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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04810507

Acronym

ACACIA

Enrollment

Registered

2021-03-23

Start date

2018-11-09

Completion date

2021-01-05

Last updated

2021-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

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

Detailed 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).

Interventions

DRUGAnagliptin BID Treatment

Continuous Glucose Monitoring with Anagliptin 100mg BID or Sitagliptin 100mg QD treatment for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

A Multi-center, Active controlled, Randomized, Double-blinded, Parallel Study

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Effect of Improving Glycemic Variability	3 days after 12 weeks treatment	Mean amplitude of glycemic excursion (MAGE)

Secondary

Measure	Time frame	Description
Average nighttime (18:00~07:59) blood glucose change after 12 weeks compared to baseline	after 12 weeks treatment	after 12 weeks compared to baseline in the test group and the control group

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026