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Completed

NCT Number: NCT04356742

Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

This study evaluates the addition of dapagliflozin in the treatment of type 2 diabetes with metformin and evogliptin combination therapy. Half of subjects will receive dapagliflozin, metformin and evogliptin, while the other half will receive placebo, metformin and evogliptin.

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Key information

Conditions

Type 2 Diabetes 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 3

Primary location

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

Bucheon-si, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with type II diabetes mellitus aged 19 years or older
  • Patients who had taken metformin(≥1000mg/day) and DPP(dipeptidyl peptidase)-4 inhibitor combination therapy(or complex is allowed) at the same dose for at least 8 weeks prior to the screening visit
  • Patients with fasting plasma glucose≤250mg/dL at the screening visit
  • Patients with 18.5kg/m^2≤BMI≤40kg/m^2 at the screening visit
  • Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study

Exclusion criteria

  • Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
  • Patients with a medical history of New York Heart Association(NYHA) class III~IV heart failure or with congestive heart failure, acute and unstable heart failure
  • Patients with severe infectious disease or severe traumatic systemic disorders
  • Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
  • Patients with galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
  • Patients with moderate to severe stage renal disease, end stage renal disease, dialysis at the time of screening visit

Treatment and study plan

Dapagliflozin 10mg

Drug

Dapagliflozin 10mg, orally, once daily, up to 24weeks

Other names: Forxiga

Placebo

Drug

Dapagliflozin Placebo, orally, once daily, up to 24weeks

Evogliptin 5mg

Drug

Evogliptin 5mg, orally, once daily for background therapy

Other names: Suganon

Metformin≥1000mg

Drug

Metformin≥1000mg, orally, daily for background therapy

Primary outcomes

  1. Change from the baseline in HbA1c (%) after 24 weeks

    Time frame: Baseline, 24 weeks

Secondary outcomes

  1. Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks

    Time frame: Baseline, 24 weeks

  2. Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks

    Time frame: Baseline, 24 weeks

  3. Change from the baseline in weight after 24 weeks

    Time frame: Baseline, 24 weeks

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2020
Registry last updated
Mar 22, 2022

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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