NCT04810507

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

1.8 years

First QC Date

March 19, 2021

Last Update Submit

March 22, 2021

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Effect of Improving Glycemic Variability

    Mean amplitude of glycemic excursion (MAGE)

    3 days after 12 weeks treatment

Secondary Outcomes (1)

  • Average nighttime (18:00~07:59) blood glucose change after 12 weeks compared to baseline

    after 12 weeks treatment

Study Arms (2)

Anagliptin arm

EXPERIMENTAL

Anagliptin 100 mg twice a day

Drug: Anagliptin BID Treatment

Sitagliptin 100mg

ACTIVE COMPARATOR

Sitagliptin 100mg once a day

Drug: Anagliptin BID Treatment

Interventions

Anagliptin BID TreatmentDRUG

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

Also known as: Sitagliptin QD Treatment
Anagliptin armSitagliptin 100mg

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 DM
  • Metformin monotherapy for more than 8 weeks and metformin ≥ 1000 mg daily for more than 8 weeks.
  • % ≤HbA1c\< 8.5%
  • Agreed Therapeutic Lifestyle change during the study period
  • Obtained Informed Consent Form

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangdong Sacred Heart Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jaewan Park

    JWPharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Multi-center, Active controlled, Randomized, Double-blinded, Parallel Study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 23, 2021

Study Start

November 9, 2018

Primary Completion

September 2, 2020

Study Completion

January 5, 2021

Last Updated

March 24, 2021

Record last verified: 2021-03

Locations

KR(1)