NCT01106131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started May 2010

Longer than P75 for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2010

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

1.9 years

First QC Date

April 16, 2010

Last Update Submit

February 13, 2013

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Glycosylated Hemoglobin (HbA1c)

    Baseline, 24 weeks

Secondary Outcomes (4)

  • 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

Study Arms (2)

CKD-501 0.5mg

EXPERIMENTAL
Drug: CKD-501 0.5mg

Pioglitazone 15mg

ACTIVE COMPARATOR
Drug: Pioglitazone 15mg

Interventions

CKD-501 0.5mgDRUG

CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with metformin.

Also known as: Lobeglitazone
CKD-501 0.5mg
Pioglitazone 15mgDRUG

Pioglitazone 15mg, orally, 1 tablet or 2 tablet(if confirmed case) once a day for 24weeks with metformin.

Pioglitazone 15mg

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33099742DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lobeglitazonePioglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • SungWoo Park, M.D., Ph.D.

    Kangbuk Samsung Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2010

First Posted

April 19, 2010

Study Start

May 1, 2010

Primary Completion

April 1, 2012

Study Completion

November 1, 2012

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

KR(1)