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Completed

NCT Number: NCT01529528

A Study to Efficacy and Safety of CWP-0403 in Type 2 Diabetes Mellitus Patients

This trial is to evaluate the efficacy and safety of CWP-0403 at 100 mg or 200 mg twice daily compared with placebo in type 2 diabetic patients with inadequate glycemic control by diet therapy or combination of diet and exercise therapy.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kangbuk Samsung Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 DM patients
  • Subjects who couldn't control the blood glucose despite of a dietary and exercise therapy more than 6 weeks at screening visit
  • FPG ≤ 270mg/dL at screening visit
  • Patients who consent to participate in this trial by written Informed Consent Form

Exclusion criteria

  • Type 1 DM or secondary diabetes
  • Subjects who are administrating insulin or need to insulin therapy
  • History of oral anti-hyperglycemic drugs within 6 weeks before screening visit
  • Body mass index < 20 kg/m2 or > 40.0kg/m2
  • Subjects who are assessed to be inappropriate for this trial by investigator

Treatment and study plan

Anagliptin

Drug

Anagliptin 100mg, tablet, BID

Placebo of Anagliptin

Drug

Placebo of Anagliptin 100mg, tablet, BID

Primary outcomes

  1. The Change in HbA1c from baseline to week24

    Time frame: 0wk, 8wk, 16wk, 24wk

Secondary outcomes

  1. The proportion of subjects achieving HbA1c<6.5% at week24

    Time frame: 0wk, 8wk, 16wk, 24wk

  2. The proportion of subjects achieving HbA1c<7% at week24

    Time frame: 0wk, 8wk, 16wk, 24wk

  3. The change from baseline to week 24: Fasting plasma glucose

    Time frame: 0wk, 24wk

  4. change from baseline to week 24 in Fasting serum insulin

    Time frame: 0 wk, 24 wk

  5. change from baseline to week 24 in Fasting serum pro-insulin

    Time frame: 0 wk, 24wk

  6. change in from baseline to week 24 fasting serum c-peptide

    Time frame: 0wk, 24wk

  7. change from baseline to week 24 in HOMA-β

    Time frame: owjm 24wk

  8. change from baseline to week 24 in HOMA-IR

    Time frame: 0wk, 24 wk

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

A Multicenter, Randomized, Double Blind, Placebo Controlled, Therapeutic Confirmatory Trial(Phase 3) to Evaluate Efficacy and Safety of CWP-0403 in Type 2 DM Patients

Acronym: CWP-DIANA-301

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 9, 2012
Registry last updated
Jan 4, 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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