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

D

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

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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