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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01529541

Acronym

CWP-DIANA-302

Enrollment

200

Registered

2012-02-09

Start date

2011-05-31

Completion date

2013-10-31

Last updated

2014-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

CWP-0403, Sitagliptin, Metformin, type 2 DM

Brief 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.

Interventions

DRUGAnagliptin

Anagliptin 100mg, tablet, twice a day (BID)

DRUGSitagliptin

Sitagliptin 100mg, tablet, once a day (QD)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The Change in HbA1c from baseline to week24.	0wk, 8wk, 16wk, 24wk

Secondary

Measure	Time frame
change from baseline to week 24: Fasting serum insulin	0wk, 24 wk
change from baseline to week 24 in Fasting serum pro-insulin	0wk, 24wk
The proportion of subjects achieving HbA1c<7% at week24	0wk, 8wk, 16wk, 24wk
The change from baseline to week 24: Fasting plasma glucose	0wk, 24wk
change from baseline to week 24 in Fasting serum c-peptide	0wk, 24wk
change from baseline to week 24 in HOMA-β	0wk, 24 wk
change from baseline to week 24 in HOMA-IR	0wk, 24 wk
The proportion of subjects achieving HbA1c<6.5% at week24	0wk, 8wk, 16wk, 24wk

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026