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

Type 2 Diabetes Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04356742
• Other study ID #: DA1229_DMTD2_III
• Status: Completed
• Phase: Phase 3
• Start date: May 26, 2020
• Est. completion date: February 23, 2022

Study information

• Verified date: March 2022
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: February 23, 2022
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Dapagliflozin 10mg
Dapagliflozin 10mg, orally, once daily, up to 24weeks
• Placebo
Dapagliflozin Placebo, orally, once daily, up to 24weeks
• Evogliptin 5mg
Evogliptin 5mg, orally, once daily for background therapy
• Metformin=1000mg
Metformin=1000mg, orally, daily for background therapy

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea Bucheon St. Mary's Hospital	Bucheon

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from the baseline in HbA1c (%) after 24 weeks		Baseline, 24 weeks
Secondary	Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks		Baseline, 24 weeks
Secondary	Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks		Baseline, 24 weeks
Secondary	Change from the baseline in weight after 24 weeks		Baseline, 24 weeks