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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: D745 formulation I; Drug: D745 formulation II; Drug: D745 Placebo

• Registration Number: NCT05566028
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-09-30
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-04
• Study Start: 2022-10-12
• Primary Completion: 2024-01-10
• Study Completion: 2024-07-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Expermental group 1	D745 formulation I	Pateints assigned to this group are treated with D150, D759 and D745 formulation I
Experimental group 2	D745 formulation II	Pateints assigned to this group are treated with D150, D759 and D745 formulation II
Placebo group	D745 Placebo	Pateints assigned to this group are treated with D150, D759 and D745 placebo

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c	Baseline, 24 week

Secondary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c	Baseline, 12 week
Change from baseline in Fasting plasma glucose	Baseline, 12 week, 24 week

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of