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Completed

NCT Number: NCT05566028

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D745 formulation I

Drug

QD for 24 weeks or 52 weeks(if extension study) with D150 and D759

D745 formulation II

Drug

QD for 24 weeks or 52 weeks(if extension study) with D150 and D759

D745 Placebo

Drug

QD for 24 weeks or 52 weeks(if extension study) with D150 and D759

Primary outcomes

  1. Change from baseline in HbA1c

    Time frame: Baseline, 24 week

Secondary outcomes

  1. Change from baseline in HbA1c

    Time frame: Baseline, 12 week

  2. Change from baseline in Fasting plasma glucose

    Time frame: Baseline, 12 week, 24 week

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2022
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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