Efficacy and Safety of CKD-501 Added to D150 Plus D745 10mg Therapy in Patients With Type 2 Diabetes

NCT03739125 | Completed Phase 3

• 1 other identifier: 19DM16022
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to prove that the group treated with CKD-501 in combination added that the reduction of glycated hemoglobin superior to placebo treated group added in combination.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Glycosylated Hemoglobin (HbA1c)

  Baseline, 24 weeks

Secondary Outcomes (17)

• Change from baseline in Glycosylated Hemoglobin (HbA1c)

  Baseline, 52 weeks

• Change from baseline in Fasting plasma glucose

  Baseline, 24 weeks, 52weeks

• Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance)

  Baseline, 24 weeks, 52weeks

• Change from baseline in HOMA-β(Homeostasis Model Assessment of β-cell function)

  Baseline, 24 weeks, 52weeks

• Change from baseline in QUICKI(Quantitative Insulin Check Index)

  Baseline, 24 weeks, 52weeks

Study Arms (2)

CKD-501 0.5mg

EXPERIMENTAL

CKD-501 0.5mg

Drug: CKD-501 0.5mg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

CKD-501 0.5mg DRUG

CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with D150 and D745

Also known as: Lobeglitazone

CKD-501 0.5mg

Placebo DRUG

orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with D150 and D745

Placebo

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 19 years and 75 years old(male or female)
• Type Ⅱ diabetes mellitus
• The patient who has been taking oral hypoglycemic agent at least 8weeks with HbA1c 7 to 10% at screening test
• BMI between 21kg/㎡ and 40kg/㎡
• C-peptide level is over 1.0 ng/ml
• Agreement with written informed consent
• HbA1c 7 to 10% after Run-in period

You may not qualify if:

• Type I diabetes or secondary diabetes
• Continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening
• Treatment with TZD within 3months or patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with TZD, SGLT2, BU
• Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
• Treatment with anti-obesity drugs within 3months
• Past history: lactic acidosis or metformin contraindication
• Acute or chronic metabolic acidosis including diabetic ketoacidosis
• History of proliferative diabetic retinopathy
• Severe infection, severe injury patients, patients of pre and post operation
• Patients with urinary tract infection including urinary tract sepsis and pyelonephritis
• Malnutrition, weakness, starvation, hyposthenia, pituitary insufficiency or adrenal insufficiency
• History of malignant tumor within 5years
• Drug abuse or history of alcoholism
• Severe pulmonary dysfunction, severe GI disorder
• History of myocardial infarction, heart failure, cerebral infarction, cerebral hemorrhage or unstable angina within 6 months

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

MeSH Terms

Interventions

lobeglitazone

Study Officials

• BongSoo Cha, Ph.D

  Severance Hospital, Yonsei University Health System

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: November 13, 2018
• Study Start: November 7, 2017
• Primary Completion: May 25, 2020
• Study Completion: December 2, 2020
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)