NCT01370707

Brief Summary

The aim of this study is to evaluate the efficacy and safety fo CJ-30001/CJ-30002.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
187

participants targeted

Target at P25-P50 for phase_3 diabetes-mellitus

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

21 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

April 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

1.3 years

First QC Date

June 2, 2011

Last Update Submit

February 13, 2013

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c at week 24

    Baseline, week 24

Secondary Outcomes (11)

  • Change from baseline in HbA1c, FPG, insulin and GLP-1 at week 4, 8, 12, 18, 24

    Baseline, week 4, 8, 12, 18, 24

  • Change from baseline in 2hr PPG and postprandial insulin at week 24

    Baseline, week 24

  • Change from baseline in FPG and HbA1c according to HbA1c at baseline(7~8%,8~9%, 9~10%, 10~11%)

    Baseline, week 4, 8, 12, 18, 24

  • Percentage of patients achieving HbA1c <7% at week 24

    week 24

  • Percentage of patients achieving HbA1c <6.5% at week 24

    week 24

  • +6 more secondary outcomes

Study Arms (2)

Metformin

ACTIVE COMPARATOR
Drug: Metformin

CJ-30001/CJ-30002

EXPERIMENTAL
Drug: CJ-30001/CJ-30002

Interventions

MetforminDRUG

1000\~1500mg/day, 24weeks

Metformin
CJ-30001/CJ-30002DRUG

0.6/1500mg\~0.9/1500mg/day, 24weeks

CJ-30001/CJ-30002

Eligibility Criteria

Age20 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with Type 2 Diabetes Mellitus
  • \~69 years old
  • BMI \< 30kg/m2
  • HbA1c between 7% and 11%
  • receiving no oral antihyperglycemic agent for more than seven days for at least 8 weeks
  • Willing to adhere to protocol requirements and sign a informed consent form

You may not qualify if:

  • Subjects with Type 1 Diabetes Mellitus
  • FPG \> 270mg/dL
  • Subjects having insulin treatment
  • Subjects with acute or chornic metaboic acidosis
  • Subjects with cardiovascular disease
  • Subjects with chronic GI disease
  • Subjects with a history of substance or alchol abuse within 1 year
  • Subjects with a history of hypersensitivity to biguanide or a-GI
  • Subjects with hypopituitarism or hypocorticalism
  • Subjects with cancer
  • Subjects who take corticosteriods or plan to take corticosteroid
  • AST and ALT \> 2.5 times the upper limit of normal
  • Creatinine level \> 1.5mg/dL in male and 1.4mg/dL in female
  • SBP \> 150mmHg or DBP \> 90mmHg
  • Subjects who work the night shift
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Bucheon St. Mary's Hospital

Bucheon-si, South Korea

Location

Seoul National University Bundang Hospital

Bundang, South Korea

Location

Kyungpook University Hospital

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

National Health Insurance Coporation Ilsan Hospital

Ilsan, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Inje University Pusan Baik Hospital

Pusan, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Eulji Medical Center

Seoul, South Korea

Location

Hallym University Medical Center(Gangdong)

Seoul, South Korea

Location

Hallym University Medical Center(Gangnam)

Seoul, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyung Hee University Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul St. Mary's hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

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

Study Record Dates

First Submitted

June 2, 2011

First Posted

June 10, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

KR(21)