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

Type 2 Diabetes Mellitus Clinical Trial

— CWP-DIANA-301  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529528
• Other study ID #: CWP-DIANA-301
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2012
• Last updated: January 2, 2013
• Start date: May 2011
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: November 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Anagliptin
Anagliptin 100mg, tablet, BID
• Anagliptin
Anagliptin 100mg, tablet, BID
• Placebo of Anagliptin
Placebo of Anagliptin 100mg, tablet, BID

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change in HbA1c from baseline to week24		0wk, 8wk, 16wk, 24wk	No
Secondary	The proportion of subjects achieving HbA1c<6.5% at week24		0wk, 8wk, 16wk, 24wk	No
Secondary	The proportion of subjects achieving HbA1c<7% at week24		0wk, 8wk, 16wk, 24wk	No
Secondary	The change from baseline to week 24: Fasting plasma glucose		0wk, 24wk	No
Secondary	change from baseline to week 24 in Fasting serum insulin		0 wk, 24 wk	No
Secondary	change from baseline to week 24 in Fasting serum pro-insulin		0 wk, 24wk	No
Secondary	change in from baseline to week 24 fasting serum c-peptide		0wk, 24wk	No
Secondary	change from baseline to week 24 in HOMA-ß		owjm 24wk	No
Secondary	change from baseline to week 24 in HOMA-IR		0wk, 24 wk	No