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Diabetes MellitusPhase 3NCT01370707

A Study to Evaluate the Efficacy and Safety of CJ-30001 and CJ-30002 in Type 2 Diabetes Mellitus Patients

A Phase 3 study testing Metformin and CJ-30001/CJ-30002 in people with Diabetes Mellitus, run by HK inno.N Corporation at 21 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 69 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Metformin and CJ-30001/CJ-30002
Could I receive a placebo?
No, everyone receives an active treatment
How many people
187 participants
Where
21 sitesSouth Korea
Study dates
Apr 2011to Jul 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with Type 2 Diabetes Mellitus
  • 20~69 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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
  • Female subjects who are pregnant, breastfeeding or not using medically acceptable birth control
  • Subjects who have participated in other study within 3 months
  • Subjects judged to be unsuitable for this trial by investigator

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

South Korea21 sites

  • Bucheon St. Mary's Hospital

    Bucheon-si

  • Seoul National University Bundang Hospital

    Bundang

  • Kyungpook University Hospital

    Daegu

  • Yeungnam University Medical Center

    Daegu

  • National Health Insurance Coporation Ilsan Hospital

    Ilsan

  • Inha University Hospital

    Incheon

  • Chonbuk National University Hospital

    Jeonju

  • Inje University Pusan Baik Hospital

    Pusan

  • Pusan National University Hospital

    Pusan

  • Asan Medical Center

    Seoul

  • Eulji Medical Center

    Seoul

  • Hallym University Medical Center(Gangdong)

    Seoul

  • Hallym University Medical Center(Gangnam)

    Seoul

  • Kangbuk Samsung Hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Kyung Hee University Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul St. Mary's hospital

    Seoul

  • Severance Hospital

    Seoul

  • Ajou University Hospital

    Suwon

  • Uijeongbu St. Mary's Hospital

    Uijeongbu-si

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of CJ-30001 and CJ-30002 in Patients With Type 2 Diabetes and Inadequate Glycemic Control ; Phase III Study

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

Being tested
Metformin, CJ-30001/CJ-30002
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    1000~1500mg/day, 24weeks

  • CJ-30001/CJ-30002Drug

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

Study groups in NCT01370707
Study groupRoleWhat they receive
MetforminActive comparatorNot described
Receives: Drug: Metformin
CJ-30001/CJ-30002ExperimentalNot described
Receives: Drug: CJ-30001/CJ-30002

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in HbA1c at week 24

    Measured: Baseline, week 24

Secondary outcomes (11)

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

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

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

    Measured: Baseline, week 24

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

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

  4. Percentage of patients achieving HbA1c <7% at week 24

    Measured: week 24

  5. Percentage of patients achieving HbA1c <6.5% at week 24

    Measured: week 24

  6. Percentage of patients reaching FPG <126mg/dL at week 24

    Measured: week 24

  7. Percentage of patients reaching 2hr PPG <200mg/dL at week 24

    Measured: week 24

  8. Percentage of patients adjusting to the high dose

    Measured: week 24

  9. Percentage of withdrawing patients due to uncontrolled glucose

    Measured: week 24

  10. Change from baseline in serum lipid(T. cholesterol, HDL, LDL, TG) at week 24

    Measured: week 24

  11. Glycemic variability

    Glycemic variability is measured by M-value. M-value = ∑{|10*log(blood glucose/100)|3}/n+{Max(blood glucose)-Min(blood glucose)}/20, M<19: good, 19≤M<32: fair, 32≤M: poor

    Measured: Baseline, week 8, 18, 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01370707
Sponsor's protocol ID
CJ_VCM_301
Status last verified
Feb 2013
First submitted
2 Jun 2011
Last updated
15 Feb 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin and CJ-30001/CJ-30002 in people with Diabetes Mellitus, run by HK inno.N Corporation at 21 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in HbA1c at week 24 (time frame: Baseline, week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01370707.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013.

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