Efficacy and Safety of CKD-501 Versus Pioglitazone When Added to Metformin

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: CKD-501 0.5mg; Drug: Pioglitazone 15mg

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.

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CKD-501 0.5mg	Drug: CKD-501 0.5mg; CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with metformin.; Other Names: Lobeglitazone
ACTIVE_COMPARATOR: Pioglitazone 15mg	Drug: Pioglitazone 15mg; Pioglitazone 15mg, orally, 1 tablet or 2 tablet(if confirmed case) once a day for 24weeks with metformin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Glycosylated Hemoglobin (HbA1c)	Baseline, 24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in glycemic parameters	Baseline, 24 weeks
Change from baseline in HbA1c target achievement rate (HbA1c < 7%)	Baseline, 24 weeks
Change from baseline in lipid parameters	Baseline, 24 weeks
Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse events	Baseline, 24 weeks

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Study Chair: SungWoo Park, M.D., Ph.D., Kangbuk Samsung Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: April 16, 2010
• First Submitted That Met QC Criteria: April 16, 2010
• First Posted (ESTIMATE): April 19, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 13, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Pioglitazone
• Other Study ID Numbers: 19DM09F