NCT01030679

Brief Summary

The purpose of this study is to assess the safety and effectiveness of three doses of CKD-501 compared to placebo in lowering fasting plasma glucose levels in people with type 2 diabetes for 8 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2007

Typical duration for phase_2 diabetes-mellitus-type-2

Geographic Reach
1 country

8 active sites

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

Study Start

First participant enrolled

July 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2009

Completed
Last Updated

December 16, 2009

Status Verified

December 1, 2009

Enrollment Period

1.3 years

First QC Date

December 9, 2009

Last Update Submit

December 14, 2009

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, type 2Glitazone

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in fasting plasma glucose at 8 weeks

    8 weeks

Secondary Outcomes (3)

  • Change from baseline in Glycemic parameters after 8 weeks

    8 weeks

  • Change from baseline in Lipid parameters after 8 weeks

    8 weeks

  • Adverse event profile after 8 weeks of treatment

    8 weeks

Study Arms (4)

CKD-501 0.5mg

EXPERIMENTAL
Drug: CKD-501 0.5mg

CKD-501 1mg

EXPERIMENTAL
Drug: CKD-501 1mg

CKD-501 2mg

EXPERIMENTAL
Drug: CKD-501 2mg

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CKD-501 0.5mgDRUG

0.5 mg/tablet, orally, 1 tablet once daily for 8 weeks

Also known as: Lobeglitazone
CKD-501 0.5mg
CKD-501 1mgDRUG

1 mg/tablet, orally, 1 tablet once daily for 8 weeks

Also known as: Lobeglitazone
CKD-501 1mg
CKD-501 2mgDRUG

2 mg/tablet, orally, 1 tablet once daily for 8 weeks

Also known as: Lobeglitazone
CKD-501 2mg
PlaceboDRUG

orally, 1 tablet once daily for 8 weeks

Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type Ⅱ diabetes mellitus
  • Fasting Plasma Glucose(FPG)≥ 126 and ≤ 270
  • HbA1c between 7 and 11%
  • Body mass index (BMI) in the range 21-40
  • The patients who has been taking oral hypoglycemic agent or diet therapy before minimum 1 month
  • Agreement with written informed consent

You may not qualify if:

  • Type I diabetes, gestational diabetes or secondary diabetes
  • Treatment with insulin(over 1month) within 3 months
  • Fasting Plasma Glucose level is over 270 mg/dl
  • Triglyceride level is 500 mg/dl and over
  • Uncontrollable hypertension
  • History of myocardial infarction, heart failure, cerebral infarction, hematencephalon or unstable angina within 6 months
  • Severe hepatic dysfunction: AST, ALT, Total bilirubin, ALP level over or equal to 3 times as high as upper normal limit(UNL)
  • Severe renal dysfunction: Renal failure or serum creatinine greater than 30% normal limit
  • Needs treatment for acute disease, uncontrolled other diseae or diabetic complications
  • In treatment concomitant drug having severe risk drug interaction with investigational drug
  • History of cancer within 5 years
  • History of drug abuse or alcoholism
  • Hepatitis B Antigen(HBsAg) test is positive
  • Treatment systemic or inhalant corticosteroids within 1 month prior to Screening
  • Patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

The Inje University Medical Center

Busan, South Korea

Location

The Yeungnam University Hospital

Daegu, South Korea

Location

The Chtholic University of Korea Uijeongbu St. Mary's Hospital

Gyeonggi-do, South Korea

Location

The Seoul National Univertisy Bundang Hospital

Gyeonggi-do, South Korea

Location

The Wonju Christian Hospital

Kangwon-Do, South Korea

Location

The Inje University Sanggye-Paik Hospital

Seoul, South Korea

Location

The Korea University Anam Hospital

Seoul, South Korea

Location

The Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lobeglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Dongseop Choi, MD.,Ph.D.

    The Korea University Anam Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 9, 2009

First Posted

December 11, 2009

Study Start

July 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

December 16, 2009

Record last verified: 2009-12

Locations

KR(8)