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

• ClinicalTrials.gov Identifier: NCT01106131
• Recruitment Status: Completed
• First Posted: April 19, 2010
• Last Update Posted: February 15, 2013
• Sponsor: Chong Kun Dang Pharmaceutical
• Information provided by (Responsible Party): Chong Kun Dang Pharmaceutical

Study Description

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

• 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

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

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

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• 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

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

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