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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: CKD-501 0.5mg; Drug: Pioglitazone 15mg	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	253 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
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 Start Date :	May 2010
Actual Primary Completion Date :	April 2012
Actual Study Completion Date :	November 2012

Arms and Interventions

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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 Name: 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.

Outcome Measures

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Primary Outcome Measures :

1. Change from baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, 24 weeks ]

Secondary Outcome Measures :

1. Change from baseline in glycemic parameters [ Time Frame: Baseline, 24 weeks ]
2. Change from baseline in HbA1c target achievement rate (HbA1c < 7%) [ Time Frame: Baseline, 24 weeks ]
3. Change from baseline in lipid parameters [ Time Frame: Baseline, 24 weeks ]
4. Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse events [ Time Frame: Baseline, 24 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Chong Kun Dang Pharmaceutical

Investigators

Study Chair:	SungWoo Park, M.D., Ph.D.	Kangbuk Samsung Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:	NCT01106131 History of Changes
Other Study ID Numbers:	19DM09F
First Posted:	April 19, 2010
Last Update Posted:	February 15, 2013
Last Verified:	February 2013

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases	Pioglitazone; Metformin; Hypoglycemic Agents; Physiological Effects of Drugs