Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 Diabetes

Dong-A ST

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: evogliptin

Drug: Sitagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02949193

DA1229_DMC_III

Details and patient eligibility

About

This is a randomized, double-blind, active-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

Full description

Evogliptin 5mg Group: Administration with Evogliptin 5mg add-on to metformin for 0-52 weeks.
Sitagliptin 100mg Group: Administration with Sitagliptin 100mg add-on to metformin for 0-24 weeks, and with Evogliptin 5mg add-on to metformin for 24-52 weeks.

Enrollment

222 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects with 6.5%≤HbA1c≤11.0% at screening
Subjects treated with 1,000mg/day or higher dose of metformin for at least 6 weeks prior to screening among people treated with metformin monotherapy for at least 12 weeks before screening
Subjects with 20kg/m2≤BMI≤40kg/m2 at screening

Exclusion criteria

Subjects with fasting plasma glucose≥270mg/dL at screening
Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
Subjects with history of myocardial infarction, cerebral infarction within 6 months prior to screening
Subjects with ALT and AST 2.5 times or higher than upper normal range