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

Dong-A ST

Status and phase: Completed; Phase 3

Conditions: Type2 Diabetes

Treatments: Drug: Metformin ≥ 1000mg; Drug: Evogliptin 5mg; Drug: Evogliptin Placebo; Drug: Dapagliflozin 10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04170998

DA1229_DMTD_III

Details and patient eligibility

About

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

Enrollment: 283 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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283 participants in 2 patient groups, including a placebo group

Evogliptin 5mg group

Experimental group

Description:

Evogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d

Treatment:

Drug: Dapagliflozin 10mg

Drug: Evogliptin 5mg

Drug: Metformin ≥ 1000mg

Evogliptin Placebo group

Placebo Comparator group

Description:

Evogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d

Treatment:

Drug: Dapagliflozin 10mg

Drug: Evogliptin Placebo

Drug: Metformin ≥ 1000mg