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CompletedNCT03739125Updated Aug 25, 2021

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

A Phase 3 interventional study of CKD-501 0.5mg and Placebo in Type2 Diabetes, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-25.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Nov 2017, registered Feb 2018).
Phase
Phase 3
Study type
Interventional
Enrollment
226
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

The aim of this phase III study was to evaluate the efficacy and safety of additional combined CKD-501 administration for 24 weeks in patients with type 2 diabetes who were not adequately controlled for blood glucose by the combination of D150 and D745 10mg .

Furthermore, the extension study for additional 28 weeks is designed to confirm long term safety of CKD-501 as an oral hypoglycemic agent.

02

Conditions studied

  • Type2 Diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 226 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Fasting Plasma Glucose level is over 270 mg/dl
  • Triglyceride level is 500 mg/dl and over
  • Significant abnormal liver dysfunction
  • Anemia
  • Abnormality of thyroid function(out of significant normal TSH range )
  • eGFR is less than 60ml/min/1.73m\^2
  • Pregnant women or nursing mothers
  • Fertile women who not practice contraception with appropriate methods
  • Participated in other trial within 4 weeks
  • Participating in other trial at present
  • In investigator's judgment
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
226 participants (actual)

Study arms

  • Experimental
    CKD-501 0.5mg

    CKD-501 0.5mg

    Drug: CKD-501 0.5mg

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

Interventions

  • DrugCKD-501 0.5mg

    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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Change from baseline in Glycosylated Hemoglobin (HbA1c)

    Time frame: Baseline, 24 weeks

Secondary outcomes

  1. Change from baseline in Glycosylated Hemoglobin (HbA1c)

    Time frame: Baseline, 52 weeks

  2. Change from baseline in Fasting plasma glucose

    Time frame: Baseline, 24 weeks, 52weeks

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

    Time frame: Baseline, 24 weeks, 52weeks

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

    Time frame: Baseline, 24 weeks, 52weeks

  5. Change from baseline in QUICKI(Quantitative Insulin Check Index)

    Time frame: Baseline, 24 weeks, 52weeks

  6. HbA1c target achievement rate at 24, 52weeks(HbA1c < 6.5%, 7%)

    Time frame: Baseline, 24 weeks, 52weeks

  7. Change from baseline in Total Cholesterol

    Time frame: Baseline, 24 weeks, 52weeks

  8. Change from baseline in Triglycerides

    Time frame: Baseline, 24 weeks, 52weeks

  9. Change from baseline in LDL-Cholesterol

    Time frame: Baseline, 24 weeks, 52weeks

  10. Change from baseline in HDL-Cholesterol

    Time frame: Baseline, 24 weeks, 52weeks

  11. Change from baseline in non-HDL-Cholesterol

    Time frame: Baseline, 24 weeks, 52weeks

  12. Change from baseline in Small Dense LDL-Cholesterol

    Time frame: Baseline, 24 weeks, 52weeks

  13. Change from baseline in FFA(Free Fatty Acid)

    Time frame: Baseline, 24 weeks, 52weeks

  14. Change from baseline in Apo-AⅠ

    Time frame: Baseline, 24 weeks, 52weeks

  15. Change from baseline in Apo-B

    Time frame: Baseline, 24 weeks, 52weeks

  16. Change from baseline in Apo-CⅢ

    Time frame: Baseline, 24 weeks, 52weeks

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

    Time frame: Baseline, 24 weeks, 52weeks

07

Study locations

1 site
  • Severance Hospital, Yonsei University Health System
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03739125
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
Nov 13, 2018
Start date
Nov 7, 2017
Primary completion
May 25, 2020
Completion
Dec 2, 2020
Last update
Aug 25, 2021

Study contacts

BongSoo Cha, Ph.D
study chair · Severance Hospital, Yonsei University Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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