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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-501 0.5mg
Pioglitazone 15mg
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kangbuk Samsung Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CKD-501 0.5mg

Pioglitazone 15mg

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in Glycosylated Hemoglobin (HbA1c)

Secondary Outcome Measures

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

Full Information

First Posted
April 16, 2010
Last Updated
February 13, 2013
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01106131
Brief Title
Efficacy and Safety of CKD-501 Versus Pioglitazone When Added to Metformin
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 Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CKD-501 0.5mg
Arm Type
Experimental
Arm Title
Pioglitazone 15mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CKD-501 0.5mg
Other Intervention Name(s)
Lobeglitazone
Intervention Description
CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with metformin.
Intervention Type
Drug
Intervention Name(s)
Pioglitazone 15mg
Intervention Description
Pioglitazone 15mg, orally, 1 tablet or 2 tablet(if confirmed case) once a day for 24weeks with metformin.
Primary Outcome Measure Information:
Title
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Time Frame
Baseline, 24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in glycemic parameters
Time Frame
Baseline, 24 weeks
Title
Change from baseline in HbA1c target achievement rate (HbA1c < 7%)
Time Frame
Baseline, 24 weeks
Title
Change from baseline in lipid parameters
Time Frame
Baseline, 24 weeks
Title
Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse events
Time Frame
Baseline, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SungWoo Park, M.D., Ph.D.
Organizational Affiliation
Kangbuk Samsung Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kangbuk Samsung Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33099742
Citation
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.
Results Reference
derived

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

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