Efficacy and Safety of CKD-501 Added to D150 Plus D745 25mg Therapy in Patients With Type 2 Diabetes

NCT03627182 | Unknown Phase 3

• 1 other identifier: 19DM17015
• Study Type: interventional
• Target: 240
• 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, 52 weeks

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

  Baseline, 24 weeks, 52 weeks

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

  Baseline, 24 weeks, 52 weeks

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

  Baseline, 24 weeks, 52 weeks

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 0.5mg

CKD-501 0.5mg

Placebo DRUG

Placebo, orally, 1 tablet once a day for 24weeks with D150 and D745. CKD-501 placebo will be changed to CKD-501 from extension stydy to EOS(end of study).

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
• Body Mass Index between 21kg/㎡ and 40kg/㎡
• C-peptide \> 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 Thiazolidinedione within 3months or patient who has experience such as hypersensitivity reaction, serious adverse event with Thiazolidinedione(TZD), sodium glucose cotransporter 2(SGLT2) inhibitor, Biguanide.
• 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, genetic problem such as galactose intolerance, etc.
• Acute or chronic metabolic acidosis including diabetic ketoacidosis
• History of proliferative diabetic retinopathy
• Patient with severe infection, severe injury
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

lobeglitazone

Study Officials

• BongSoo Cha, Ph.D

  Severance Hospital, Yonsei University Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BongSoo Cha, Ph.D

CONTACT

82-2-2228-1962; bscha@yuhs.ac

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: July 4, 2018
• First Posted: August 13, 2018
• Study Start: April 26, 2018
• Primary Completion: March 29, 2022
• Study Completion: February 10, 2023
• Last Updated: August 13, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)