Clinical Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2

Daewon Pharmaceutical Co., Ltd.230 enrolled

Overview

A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2 Add-on to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin and Sitagliptin Combination Therapy

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

230

Conditions

Type 2 Diabetes

Interventions

DW1026C1DRUG

Sitagliptin 100mg+Empagliflozin 10mg

DW1026C2DRUG

Sitagliptin 100mg+Empagliflozin 25mg

DW1026SDRUG

Sitagliptin 100mg

Eligibility

Sex: ALLMin age: 19 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who are diagnosed with Type2 Diabetes * 19 ≤ Age ≤ 85 * 7.0% ≤ HbA1c ≤ 10.5% Exclusion Criteria: * Patients with a history of acute pancreatitis * Patients with a history of pre-diabetic coma * Patients with a history of diagnosis of malignant tumors within 5 years prior to visit 1

Locations (1)

Yeouido St. Mary's Hospital The Catholic University

Seoul, South Korea

Outcomes

Primary Outcomes

% change of HbA1c

% change of HbA1c in week 24 from baseline

Time frame: 24 weeks

Data from ClinicalTrials.gov

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