Efficacy and Safety of CWP-0403 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin Alone

Type 2 Diabetes Mellitus Clinical Trial

— CWP-DIANA-302  

Official title:

A Multicenter, Randomized, Double-blind, Double Dummy, Active-controlled, Therapeutic Confirmatory Trial(Phase 3) to Evaluate the Efficacy and Safety of CWP-0403 Compared With Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 DM Insufficiently Controlled With Metformin Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529541
• Other study ID #: CWP-DIANA-302
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2012
• Last updated: May 12, 2014
• Start date: May 2011
• Est. completion date: October 2013

Study information

• Verified date: May 2014
• 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 compared to Sitagliptin by proving non-inferiority in patients with type 2 Diabetes Mellitus insufficiently controlled with metformin alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients who had diagnosed with type 2 DM before 3 months

• Men and women between the age of = 19 and = 75 years

• FPG = 270 mg/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 oral anti-hyperglycemic drugs or have to take a medicine

• 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, twice a day (BID)
• Sitagliptin
Sitagliptin 100mg, tablet, once a day (QD)

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<7% at week24		0wk, 8wk, 16wk, 24wk	No
Secondary	The proportion of subjects achieving HbA1c<6.5% 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: Fasting serum insulin		0wk, 24 wk	No
Secondary	change from baseline to week 24 in Fasting serum pro-insulin		0wk, 24wk	No
Secondary	change from baseline to week 24 in Fasting serum c-peptide		0wk, 24wk	No
Secondary	change from baseline to week 24 in HOMA-ß		0wk, 24 wk	No
Secondary	change from baseline to week 24 in HOMA-IR		0wk, 24 wk	No