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Recruiting

NCT Number: NCT07442006

Glycemic Variability of Combination Therapies in T2DM

Glycemic Variability of Combination Therapies in T2DM

Recruiting

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Seoul, South Korea

Location status: Recruiting

Location contact

Sung Rae Kim

CONTACT

[email protected]

82-32-340-7013

About this study

A multicenter study to evaluate efficacy and safety

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

empagliflozin/metformin

Drug

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

Anagliptin

Drug

100 mg, for 12 weeks (PO, BID)

metformin

Drug

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

Empagliflozin/Linagliptin

Drug

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

Primary outcomes

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

    Time frame: Baseline to week 12

Secondary outcomes

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

    Time frame: Baseline to week 12

  2. Change from baseline in mean blood glucose at 12 weeks

    Time frame: Baseline to week 12

  3. Change from baseline in HbA1c at 12 weeks

    Time frame: Baseline to week 12

  4. Change from baseline in FPG at 12 weeks

    Time frame: Baseline to week 12

  5. 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]

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Saemi Kang

CONTACT

[email protected]

82-2-840-6902

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

A Multicenter Study to Evaluate Efficacy and Safety

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

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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