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Completed

NCT Number: NCT00888719

Therapeutic Exploratory Study of CWP-0403

Objective of the trial is to assess dose-dependency, efficacy and safety and to estimate optimum dosage for confirmatory study of CWP-0403 50mg, 100mg given twice daily for 12 weeks to type 2 diabetes patients who are insufficiently controlled by diet and exercise in comparison to placebo.

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chonbuk National University Hospital, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age of≥25 and <75 with typeⅡ DM patients
  • Patients whose level of HbA1c is over 7.0% and less than 10% within 4weeks of screening registration
  • In spite of dietary and exercise treatment over 8weeks, the level of HbA1c is over 6.5% and less than 10%.
  • BMI between 20kg/㎡ and 40kg/㎡
  • Out patients
  • patients who agree the trial participation with written informed consent

Exclusion criteria

  • TypeⅠDM, Gestational diabetes.
  • Patients who are being treated with insulin
  • Fasting glucose level over 250mg/dL
  • Patients who are not compliant with dietary and exercise treatment during 8 weeks of screening period. (Evaluated "Bad" and worse)
  • Severe hepatic dysfunctions (i.e.: uncompensated hepatic cirrhosis)or AST or ALT level over 2.5times as high as UNL on screening visit.
  • Severe renal dysfunctions (i.e.: renal failure) or serum creatinine level over 1.5mg/dl
  • Severe cardiac dysfunction(i.e.: heart failure ) or history of myocardial infarction within 6months of screening
  • Chronic pulmonary disease or pulmonary infarction
  • Pancreatitis patients
  • Patients who are being treated for life threatening disease such as cancer, severe trauma or infection.
  • Uncontrollable diabetic complications(neuropathy, retinopathy, nephrosis)
  • Severe ketosis or experience of diabetic coma
  • Intestinal disease affecting digestion or absorption or history of GI dissection surgery except for appendectomy.
  • Pregnant, expecting to be pregnant or nursing female
  • Excessive alcohol consumption (Over 80g of alcohol/day: Over 1 bottle of 360ml Soju/day)
  • Participants of other clinical trials within 3 months of screening
  • Patients medicated with following non-concomitant medications Insulins or oral antidiabetics Oral (for more than 1 week) or IV corticosteroids (External and inhaled corticosteroids excluded) appetite suppressant exenatide or other GLP-1 analogues Other medications in development
  • Hypersensitive or intolerance to DPP4 inhibitory
  • patients who are decided to be inappropriate for this trial subject by the investigators

Treatment and study plan

CWP-0403 100mg

Drug

100mg/tablet, Twice a day, 1 tablet at a time for 12 weeks

Placebo

Drug

Tablet not containing CWP-0403 and indistinguishable from CWP-0403 50mg, 100mg tablets.

Twice a day, 1 tablet at a time for 12 weeks

CWP-0403 50mg

Drug

50mg/tablet, Twice a day, 1 tablet at a time for 12 weeks

Primary outcomes

  1. Change in HbA1c before and after treatment

    Time frame: 12 weeks

Secondary outcomes

  1. HbA1c target achievement rate(Ratio of the patients with HbA1c lower than 6.5% or 7%)

    Time frame: 12 weeks

  2. Fasting blood glucose level change and rate of change

    Time frame: 12 weeks

  3. Serum insulin, serum C-peptide level change

    Time frame: 12 weeks

  4. HOMA-R and HOMA-β change rate

    Time frame: 12 weeks

  5. Triglyceride, LDL-cholesterol and HDL-cholesterol change

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

A Prospective, Randomized, Double Blinded, Multicenter and Therapeutic Exploratory Study to Comparatively Assess Efficacy and Safety of CWP-0403 in Type 2 Diabetes Patients Who Are Insufficiently Controlled by Diet and Exercise.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 28, 2009
Registry last updated
Nov 5, 2010

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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