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

Purpose

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	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: CKD-501 0.5mg Drug: Pioglitazone 15mg	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Drug Information available for: Metformin Metformin hydrochloride Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:

Change from baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in glycemic parameters [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in HbA1c target achievement rate (HbA1c < 7%) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in lipid parameters [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse events [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: Yes ]


Enrollment:	253
Study Start Date:	May 2010
Study Completion Date:	November 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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


Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106131

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

No publications provided


Responsible Party:	Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:	NCT01106131 History of Changes
Other Study ID Numbers:	19DM09F
Study First Received:	April 16, 2010
Last Updated:	February 13, 2013
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:


Metformin Pioglitazone Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015