Glycemic Variability of Combination Therapies in T2DM

February 26, 2026 updated by: JW Pharmaceutical

A Multicenter Study to Evaluate Efficacy and Safety

Glycemic Variability of Combination Therapies in T2DM

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A multicenter study to evaluate efficacy and safety

Study Type

Interventional

Enrollment (Estimated)

178

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 Contact

Study Locations

  • South Korea
      • Seoul, South Korea
        • Recruiting
        • The Catholic University of Korea, Bucheon St. Mary's Hospital, Principal Investigator
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Inadequate glycemic control despite treatment with Metformin (≥ 1,000mg/day) and SGLT-2 inhibitor.

Exclusion Criteria:

  • History of acute or chronic metabolic acidosis
  • Moderate to severe renal impairment (eGFR < 45 mL/min/1.73m²)
  • Severe hepatic impairment
  • History of heart failure (NYHA Class III/IV)

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: Experimental
Empagliflozin/Metformin + Anagliptin
Drug: Empagliflozin/Metformin
5/500 mg, 5/1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID)
Drug: Anagliptin
100 mg, for 12 weeks (PO, BID)
Active Comparator: Active Comparator
Metformin + Empagliflozin/Linagliptin
Drug: Metformin
500 mg, 1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID)
Drug: Empagliflozin/Linagliptin
10/5 mg, for 12 weeks (PO, QD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in Mean Amplitude of Glycemic Excursion (MAGE) from baseline to week 12
Time Frame: Baseline to week 12
Baseline to week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the percentage of time spent within the target glucose range (70-180 mg/dL)
Time Frame: Baseline to week 12
Baseline to week 12
Change from baseline in mean blood glucose at 12 weeks
Time Frame: Baseline to week 12
Baseline to week 12
Change from baseline in HbA1c at 12 weeks
Time Frame: Baseline to week 12
Baseline to week 12
Change from baseline in FPG at 12 weeks
Time Frame: Baseline to week 12
Baseline to week 12
Change from baseline in HOMA-β at 12 weeks
Time Frame: Baseline to week 12
HOMA- β: 20*fasting insulin/[(fasting plasma glucose*0.0555)-3.5]
Baseline to week 12
Change from baseline in HOMA-IR at 12 weeks
Time Frame: Baseline to week 12
HOMA-IR: fasting insulin*(fasting glucose*0.0555)/22.5
Baseline to week 12

Collaborators and Investigators

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

Sponsor

JW Pharmaceutical

Investigators

  • Principal Investigator: Sung Rae Kim, The Catholic University of Korea, Bucheon St. Mary's Hospital, Principal Investigator

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)

October 29, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JW25402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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