NCT07442006

Brief Summary

Glycemic Variability of Combination Therapies in T2DM

Trial Health

77
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P50-P75 for phase_4

Timeline
9mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Oct 2025Mar 2027

Study Start

First participant enrolled

October 29, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

January 21, 2026

Last Update Submit

February 26, 2026

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Glycemic Variability

Outcome Measures

Primary Outcomes (1)

  • Mean change in Mean Amplitude of Glycemic Excursion (MAGE) from baseline to week 12

    Baseline to week 12

Secondary Outcomes (6)

  • Change in the percentage of time spent within the target glucose range (70-180 mg/dL)

    Baseline to week 12

  • Change from baseline in mean blood glucose at 12 weeks

    Baseline to week 12

  • Change from baseline in HbA1c at 12 weeks

    Baseline to week 12

  • Change from baseline in FPG at 12 weeks

    Baseline to week 12

  • Change from baseline in HOMA-β at 12 weeks

    Baseline to week 12

  • +1 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

Empagliflozin/Metformin + Anagliptin

Drug: Empagliflozin/MetforminDrug: Anagliptin

Active Comparator

ACTIVE COMPARATOR

Metformin + Empagliflozin/Linagliptin

Drug: MetforminDrug: Empagliflozin/Linagliptin

Interventions

Empagliflozin/MetforminDRUG

5/500 mg, 5/1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID)

Experimental
AnagliptinDRUG

100 mg, for 12 weeks (PO, BID)

Experimental
MetforminDRUG

500 mg, 1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID)

Active Comparator
Empagliflozin/LinagliptinDRUG

10/5 mg, for 12 weeks (PO, QD)

Active Comparator

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic University of Korea, Bucheon St. Mary's Hospital, Principal Investigator

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozinMetforminanagliptinLinagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolines

Study Officials

  • Sung Rae Kim

    The Catholic University of Korea, Bucheon St. Mary's Hospital, Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saemi Kang

CONTACT

82-2-840-6902kangsm@jwhealthcare.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, open-label, active-controlled, parallel, phase IV
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

March 2, 2026

Study Start

October 29, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)