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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: CKD-501 0.5mg; Drug: Pioglitazone 15mg

• Registration Number: NCT01106131
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Study First Submitted: 2010-04-16
• Study First Submitted QC: 2010-04-16
• Study First Posted: 2010-04-19
• Study Start: 2010-05
• Primary Completion: 2012-04
• Study Completion: 2012-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-13
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CKD-501 0.5mg	CKD-501 0.5mg	-
Pioglitazone 15mg	Pioglitazone 15mg	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Glycosylated Hemoglobin (HbA1c)	Baseline, 24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of