Clinical trial NCT01106131: Efficacy and Safety of CKD-501 Versus Pioglitazone When Added to Metformin
Official title: Efficacy and Safety of CKD-501 or Pioglitazone Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Alone: Multi Center, Randomized, Double Blind, Therapeutic Confirmatory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-04-19
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to prove effect of glucose reduction that CKD-501 and metformin combination treatment group is non inferiority compare to pioglitazone and metformin combination.

Detailed description: The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-501 and metformin combination for 24 weeks in type 2 diabetes mellitus. Furthermore, the extension study for additional 28weeks is designed to confirm long term safety of CKD-501 as an oral hypoglycemic agent.

Eligibility criteria: Inclusion Criteria:

* Between 18 years and 80 years old(male or female)
* Type Ⅱ diabetes mellitus
* The patient who has been taking oral hypoglycemic agent since 2 months 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

Exclusion Criteria:

* Type I diabetes or secondary diabetes
* Continuous or non continuous treatment(over 7 days) insulin within 3 month prior to screening
* Treatment with thiazolidinediones within 60 days or patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones
* Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
* 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 (pre and post operation)
* Oligotrophy,starvation, hyposthenia, pituitary insufficiency or capsular insufficiency
* Drug abuse or history of alcoholism
* History of myocardial infarction, heart failure, cerebral infarction, hematencephalon 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: AST, ALT level over or equal to 2.5 times, Total bilirubin level over or equal 2 times as high as upper normal limit(UNL)
* Significant abnormal renal dysfunction
* Anemia
* Abnormality of thyroid function(out of significant normal TSH range )
* Hepatitis B or C test is positive
* Pregnant women or nursing mothers
* Has a contraindication to treatment
* 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

Primary outcomes:
measure: Change from baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, 24 weeks
Secondary outcomes:
measure: Change from baseline in glycemic parameters
timeFrame: Baseline, 24 weeks
measure: Change from baseline in HbA1c target achievement rate (HbA1c < 7%)
timeFrame: Baseline, 24 weeks
measure: Change from baseline in lipid parameters
timeFrame: Baseline, 24 weeks
measure: Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse events
timeFrame: Baseline, 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: SungWoo Park, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: Kim KS, Hong S, Ahn HY, Park CY. Comparative Efficacy of Lobeglitazone Versus Pioglitazone on Albuminuria in Patients with Type 2 Diabetes Mellitus. Diabetes Ther. 2021 Jan;12(1):171-181. doi: 10.1007/s13300-020-00948-1. Epub 2020 Oct 24.