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Completed

NCT Number: NCT04810507

MAGE of Anagliptin Compared With Sitagliptin 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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kangdong Sacred Heart Hospital

Seoul, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anagliptin BID Treatment

Drug

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

Other names: Sitagliptin QD Treatment

Primary outcomes

  1. Effect of Improving Glycemic Variability

    Time frame: 3 days after 12 weeks treatment

    Mean amplitude of glycemic excursion (MAGE)

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study 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

Acronym: ACACIA

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Mar 23, 2021
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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