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

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04170998
• Other study ID #: DA1229_DMTD_III
• Status: Completed
• Phase: Phase 3
• Start date: January 2, 2020
• Est. completion date: December 8, 2021

Study information

• Verified date: December 2021
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: December 8, 2021
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients with Type II diabetes mellitus aged 19 years or older

• Subjects who performed Dual therapies (complex allowed) for one of the following, along with meals and exercise therapy

1. Subjects who are receiving metformin = 1000 mg/d and dapagliflozin 10 mg/d at the same dose for at least 8 weeks prior to the screening visit

2. Subjects who are receiving metformin = 1000 mg/d and SGLT-2 inhibitor except for dapagliflozin at the same dose for at least 8 weeks prior to the screening visit

• Subjects with 7.0%=HbA1c=10.5% at screening visit

• Subjects with fasting plasma glucose = 270mg/dL at screening visit

• Subjects with 18.5kg/m2=BMI=40kg/m2 at screening visit

Exclusion Criteria:

• Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic ketoacidosis, diabetic coma, pre-coma, lactic acidosis, and acute or chronic metabolic acidosis

• patients with Hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia

• Patients with severe infectious disease or severe traumatic systemic disorders

• End stage renal disease or dialysis patients

• Patients with Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption

• Subjects with Liver cirrhosis, chronic active hepatitis B or C, cholecystitis, acromegaly, asthma or major skin allergies

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Drug:
• Evogliptin 5mg
Participants receive Evogliptin 5mg orally once a day
• Evogliptin Placebo
Participants receive placebo to match Evogliptin 5mg orally once a day
• Dapagliflozin 10mg
Participants receive Dapagliflozin orally once a day
• Metformin = 1000mg
Metformin are administered at the same dose and formulation.

Locations

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

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 baseline in HbA1c (%) After 24 weeks		24 weeks
Secondary	Change from baseline in FPG(mg/dL) After 24 weeks		24 weeks
Secondary	Change from baseline in HbA1c response rate(<7.0% ,<6.5%) After 24 weeks		24 weeks
Secondary	Change from baseline in 7-point SMBG After 24 weeks		24 weeks