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

Type2 Diabetes Clinical Trial

Official title:

Efficacy and Safety of CKD-501 Added to D150 Plus D745 25mg Therapy in Patients With Type 2 Diabetes Inadequately Controlled With D150 Plus D745 25mg: Multi-center, Randomized, Double-blind, Parallel-group, Placebo Control, Therapeutic Confirmatory Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03627182
• Other study ID #: 19DM17015
• Status: Recruiting
• Phase: Phase 3
• Start date: April 26, 2018
• Est. completion date: February 10, 2023

Study information

• Verified date: June 2018
• Source: Chong Kun Dang Pharmaceutical
• Contact: BongSoo Cha, Ph.D
• Phone: 82-2-2228-1962
• Email: bscha[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 25mg .

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: February 10, 2023
• Est. primary completion date: March 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

• Between 19 years and 75 years old(male or female)

• Type ? 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

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 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

• History of myocardial infarction, heart failure, cerebral infarction, cerebral hemorrhage or unstable angina within 6 months

• Abnormal lab result: ? Fasting Plasma Glucose > 270 mg/dl ? Triglyceride = 500 mg/dl ? Significant liver dysfunction or AST(Aspartate transaminase)/ALT(Alanine transaminase) = normal range*3 or Total bilirubin = normal range*2 ? Hemoglobin<10.5g/dL ? Abnormality of thyroid function(significantly out of normal TSH(Thyroid Stimulating Hormone) range)

• eGFR(Estimated glomerular filtration rate) 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 or participating in other trial at present

• In investigator's judgment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Glycosylated Hemoglobin (HbA1c)		Baseline, 24 weeks
Secondary	Change from baseline in Glycosylated Hemoglobin (HbA1c)		Baseline, 52 weeks
Secondary	Change from baseline in Fasting plasma glucose		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance)		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in HOMA-ß(Homeostasis Model Assessment of ß-cell function)		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in QUICKI(Quantitative Insulin Check Index)		Baseline, 24 weeks, 52 weeks
Secondary	HbA1c target achievement rate at 24 weeks(HbA1c < 6.5%, 7%)		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in Total Cholesterol		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in Triglycerides		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in LDL-Cholesterol		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in HDL-Cholesterol		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in non-HDL-Cholesterol		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in Small Dense LDL-Cholesterol		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in FFA(Free Fatty Acid)		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in Apo-A?		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in Apo-B		Baseline, 24 weeks, 52 weeks
Secondary	Change from baseline in Apo-C?		Baseline, 24 weeks, 52 weeks
Secondary	Evaluate safety of CKD-501 from number of participants with adverse events		Baseline, 24 weeks, 52 weeks