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

Phase 3

Completed

• Conditions: Type2 Diabetes
• Interventions: Drug: Evogliptin 5mg; Drug: Evogliptin Placebo; Drug: Dapagliflozin 10mg; Drug: Metformin ≥ 1000mg

• Registration Number: NCT04170998
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-20
• Study Start: 2020-01-02
• Primary Completion: 2021-06-28
• Status Verified: 2021-12
• Study Completion: 2021-12-08
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 283

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evogliptin 5mg group	Metformin ≥ 1000mg	Evogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
Evogliptin Placebo group	Dapagliflozin 10mg	Evogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
Evogliptin Placebo group	Metformin ≥ 1000mg	Evogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
Evogliptin 5mg group	Evogliptin 5mg	Evogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
Evogliptin 5mg group	Dapagliflozin 10mg	Evogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
Evogliptin Placebo group	Evogliptin Placebo	Evogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c (%) After 24 weeks	24 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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