The Efficacy and Safety of CKD-501 Added to D150 Plus D759 Therapy in Patients With Type 2 Diabetes

NCT03641352 | Unknown Phase 3

• 1 other identifier: 19DM17012
• 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

  Baseline, 24weeks

Secondary Outcomes (17)

• Change from baseline in in Glycosylated Hemoglobin

  Baseline, 52weekes

• Change from baseline in Fasting plasma glucose

  Baseline, 24weeks, 52weeks

• HbA1c target achievement rate at 24weekes(HbA1c < 6.5%, 7%)

  Baseline, 24weeks

• Change from baseline in Total Cholesterol

  Baseline, 24weeks, 52weeks

• Evaluate safety of CKD-501 from number of participants with adverse events

  Baseline, 24weeks, 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 dqy for 24weeks or 52weeks (if extension study) with D150 and D759

Also known as: Lobeglitazone

CKD-501 0.5mg

Placebo DRUG

Placebo, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759. CKD-501 placebo will be changed to CKD-501 from extension study to EOS(end of study).

Placebo

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between 19 years and 80 years old(male or female)
• Type 2 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/m2 and 40kg/m2
• 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 1 diabetes mellitus or secondary diabetes mellitus
• Continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening
• Treatment with Thiazolidinedione(TZD) within 3 months or patient who has experience such as hypersensitivity reaction, serious adverse event with TZD, Biguanide
• Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
• Treatment with anti-obesity drugs within 3 months

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

lobeglitazone

Study Officials

• Kun ho Yoon, Ph.D

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun ho Yoon, Ph.D

CONTACT

82-2-2258-6007; yoonk@catholic.ac.kr

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 20, 2018
• First Posted: August 22, 2018
• Study Start: May 2, 2018
• Primary Completion: April 30, 2021
• Study Completion: November 30, 2022
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)