MAGE of Anagliptin Compared With Sitagliptin With Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

— ACACIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04810507
• Other study ID #: JWP-GDL-404
• Status: Completed
• Phase: Phase 4
• Start date: November 9, 2018
• Est. completion date: January 5, 2021

Study information

• Verified date: March 2021
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: January 5, 2021
• Est. primary completion date: September 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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 ?? sitagliptin

• Being pregnant or nursing or suspected of being pregnant, or

• History of participation in other clinical studies in the preceding 3 months.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Anagliptin BID Treatment
Continuous Glucose Monitoring with Anagliptin 100mg BID or Sitagliptin 100mg QD treatment for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Improving Glycemic Variability	Mean amplitude of glycemic excursion (MAGE)	3 days after 12 weeks treatment
Secondary	Average nighttime (18:00~07:59) blood glucose change after 12 weeks compared to baseline	after 12 weeks compared to baseline in the test group and the control group	after 12 weeks treatment