Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With Metformin

Celltrion606 enrolled

Overview

Phase 3 study to assess the Efficacy and Safety of CT-L03-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Empagliflozin Combination Therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

606

Conditions

T2DM

Interventions

CT-L03 Group 1DRUG

tablets, QD, oral administration

CT-L03 Group 2DRUG

tablets, QD, oral administration

PlaceboDRUG

tablets, QD, oral administration

Empagliflozin

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults at the time of signing the Informed Consent Form (ICF) * Signed the written ICF voluntarily after being fully informed of the objectives, methods, and effects of the study * Diagnosed with T2DM Exclusion Criteria: * Diagnosed with other types of diabetes than T2DM * History of hypersensitivity reaction to the components or drugs of the same class as the IP or the background therapy * Uncontrolled severe complications of diabetes

Locations (1)

Celltrion

Incheon, South Korea

Outcomes

Primary Outcomes

HbA1c

Change from Baseline in HbA1c

Time frame: Week 24 of the Treatment

Secondary Outcomes

HbA1c

Change from Baseline in HbA1c

Time frame: Week 12 of the Treatment

FPG

Change from Baseline in fasting plasma glucose

Time frame: Week 12 and 24 of the Treatment

Body weight

Change from Baseline in body weight

Time frame: Week 12 and 24 of the Treatment

Data from ClinicalTrials.gov

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