The Efficacy and Safety of D745 Added to D150 Plus D759 Therapy in Patients With Type 2 Diabetes

A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of D150, D745 and D759 Combination Therapy in Pateints With Type 2 Diabetes Inadequately Controlled With D150 Plus D759

The purpose of this study is to prove that the group treated with D745 in combination added that the reduction of HbA1c superior to placebo treated group added in combination.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: D745 formulation I; Drug: D745 formulation II; Drug: D745 Placebo

Detailed Description

The aim of this phase 3 study is to evaluate the efficacy and safety of additional combined D745 administration for 24 weeks in patient with type 2 diabetes who are no adequately controlled for blood glucose by the combination of D150 and D759

• Study Type: Interventional
• Enrollment (Anticipated): 165
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Youngmin Cho, M.D, Ph.D; Phone Number: +8202-2072-1965; Email: ymchomd@snu.ac.kr

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Recruiting
      • Seoul National University Hospital
      • Contact: Youngmin Cho, M.D, Ph.D; Phone Number: +82-2-2072-1865; Email: ymchomd@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• between 19 years and 85 years old(male or female)
• Type 2 diabetes mellitus
• BMI between 18.5kg/m2 and 40kg/m2
• Agreement with written informed consent

Exclusion Criteria:

• Type 1 diabetes mellitus or secondary diabetes mellitus
• Patients with complications of severe diabetes such as proliferative diabetic retinopathy
• Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• Patients with abnormal laboratory test results according to the protocol
• Continuous or non continuous treatment insulin within 12 weeks prior to screening
• Chronic oral or non oral corticosteroids treatment within 4 weeks prior to screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Expermental group 1; Pateints assigned to this group are treated with D150, D759 and D745 formulation I	Drug: D745 formulation I; QD for 24 weeks or 52 weeks(if extension study) with D150 and D759
Experimental: Experimental group 2; Pateints assigned to this group are treated with D150, D759 and D745 formulation II	Drug: D745 formulation II; QD for 24 weeks or 52 weeks(if extension study) with D150 and D759
Placebo Comparator: Placebo group; Pateints assigned to this group are treated with D150, D759 and D745 placebo	Drug: D745 Placebo; QD for 24 weeks or 52 weeks(if extension study) with D150 and D759

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in HbA1c	Baseline, 24 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in HbA1c	Baseline, 12 week
Change from baseline in Fasting plasma glucose	Baseline, 12 week, 24 week

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Youngmin Cho, M.D, Ph.D, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): April 16, 2024
• Study Completion (Anticipated): October 29, 2024

Study Registration Dates

• First Submitted: September 30, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: A127_02DM2210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No