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
Overview
- Phase
- Phase 3
- Intervention
- Evogliptin 5mg
- Conditions
- Type2 Diabetes
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 283
- Locations
- 1
- Primary Endpoint
- Change from baseline in HbA1c (%) After 24 weeks
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Investigators
Eligibility Criteria
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
- •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
- •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
Arms & Interventions
Evogliptin 5mg group
Evogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
Intervention: Evogliptin 5mg
Evogliptin 5mg group
Evogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
Intervention: Dapagliflozin 10mg
Evogliptin 5mg group
Evogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
Intervention: Metformin ≥ 1000mg
Evogliptin Placebo group
Evogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
Intervention: Evogliptin Placebo
Evogliptin Placebo group
Evogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
Intervention: Dapagliflozin 10mg
Evogliptin Placebo group
Evogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
Intervention: Metformin ≥ 1000mg
Outcomes
Primary Outcomes
Change from baseline in HbA1c (%) After 24 weeks
Time Frame: 24 weeks
Secondary Outcomes
- 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)