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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Dapagliflozin 10mg; Drug: Placebo; Drug: Evogliptin 5mg; Drug: Metformin≥1000mg

• Registration Number: NCT04356742
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-20
• Study First Posted: 2020-04-22
• Study Start: 2020-05-26
• Primary Completion: 2022-02-23
• Study Completion: 2022-02-23
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-20
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

1. Patients with type II diabetes mellitus aged 19 years or older
2. 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
3. Patients with fasting plasma glucose≤250mg/dL at the screening visit
4. Patients with 18.5kg/m^2≤BMI≤40kg/m^2 at the screening visit
5. Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study

Exclusion Criteria

1. Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
2. 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
3. Patients with severe infectious disease or severe traumatic systemic disorders
4. Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
5. Patients with galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
6. Patients with moderate to severe stage renal disease, end stage renal disease, dialysis at the time of screening visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin 10mg + Evogliptin 5mg + Metformin	Dapagliflozin 10mg	-
Dapagliflozin 10mg + Evogliptin 5mg + Metformin	Evogliptin 5mg	-
Dapagliflozin 10mg + Evogliptin 5mg + Metformin	Metformin≥1000mg	-
Dapagliflozin Placebo + Evogliptin 5mg + Metformin	Placebo	-
Dapagliflozin Placebo + Evogliptin 5mg + Metformin	Metformin≥1000mg	-
Dapagliflozin Placebo + Evogliptin 5mg + Metformin	Evogliptin 5mg	-

Primary Outcome Measures

Name	Time	Method
Change from the baseline in HbA1c (%) after 24 weeks	Baseline, 24 weeks

Secondary Outcome Measures

Name	Time	Method
Change from the baseline in weight after 24 weeks	Baseline, 24 weeks
Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks	Baseline, 24 weeks
Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks	Baseline, 24 weeks

Trial Locations

Locations (1)

The Catholic University of Korea Bucheon St. Mary's Hospital; 🇰🇷 Bucheon, Korea, Republic of