MAGE of Anagliptin Compared With Sitagliptin With Type 2 Diabetes Mellitus

NCT ID: NCT04810507

Last Updated: 2021-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-09

Study Completion Date

2021-01-05

Brief Summary

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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

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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).

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anagliptin arm

Anagliptin 100 mg twice a day

Group Type EXPERIMENTAL

Anagliptin BID Treatment

Intervention Type DRUG

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

Sitagliptin 100mg

Sitagliptin 100mg once a day

Group Type ACTIVE_COMPARATOR

Anagliptin BID Treatment

Intervention Type DRUG

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

Interventions

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Anagliptin BID Treatment

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

Intervention Type DRUG

Other Intervention Names

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Sitagliptin QD Treatment

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JW Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jaewan Park

Role: STUDY_DIRECTOR

JWPharmaceuticals

Locations

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Kangdong Sacred Heart Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JWP-GDL-404

Identifier Type: -

Identifier Source: org_study_id

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