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

March 22, 2021 updated by: JW Pharmaceutical

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anagliptin arm
Anagliptin 100 mg twice a day
Drug: Anagliptin BID Treatment
Continuous Glucose Monitoring with Anagliptin 100mg BID or Sitagliptin 100mg QD treatment for 12 weeks
Other Names:
  • Sitagliptin QD Treatment
Active Comparator: Sitagliptin 100mg
Sitagliptin 100mg once a day
Drug: Anagliptin BID Treatment
Continuous Glucose Monitoring with Anagliptin 100mg BID or Sitagliptin 100mg QD treatment for 12 weeks
Other Names:
  • Sitagliptin QD Treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Study Director: Jaewan Park, JWPharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2018

Primary Completion (Actual)

September 2, 2020

Study Completion (Actual)

January 5, 2021

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JWP-GDL-404

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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