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Completed

NCT Number: NCT01370707

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

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bucheon St. Mary's Hospital, Bucheon-si, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

metformin

Drug

1000~1500mg/day, 24weeks

CJ-30001/CJ-30002

Drug

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

Primary outcomes

  1. Change from baseline in HbA1c at week 24

    Time frame: Baseline, week 24

Secondary outcomes

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

    Time frame: Baseline, week 4, 8, 12, 18, 24

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

    Time frame: Baseline, week 24

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

    Time frame: Baseline, week 4, 8, 12, 18, 24

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

    Time frame: week 24

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

    Time frame: week 24

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

    Time frame: week 24

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

    Time frame: week 24

  8. Percentage of patients adjusting to the high dose

    Time frame: week 24

  9. Percentage of withdrawing patients due to uncontrolled glucose

    Time frame: week 24

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

    Time frame: week 24

  11. Glycemic variability

    Time frame: Baseline, week 8, 18, 24

    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

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 10, 2011
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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