MAGE of Anagliptin Compared With Sitagliptin With Type 2 Diabetes Mellitus

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Anagliptin BID Treatment

• Registration Number: NCT04810507
• Lead Sponsor: JW Pharmaceutical

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).

Study Timeline

• Study Start: 2018-11-09
• Primary Completion: 2020-09-02
• Study Completion: 2021-01-05
• Status Verified: 2021-03
• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-19
• Last Update Submitted: 2021-03-22
• Study First Posted: 2021-03-23
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sitagliptin 100mg	Anagliptin BID Treatment	Sitagliptin 100mg once a day
Anagliptin arm	Anagliptin BID Treatment	Anagliptin 100 mg twice a day

Primary Outcome Measures

Name	Time	Method
Effect of Improving Glycemic Variability	3 days after 12 weeks treatment	Mean amplitude of glycemic excursion (MAGE)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kangdong Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of