Efficacy and Safety of CWP-0403 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin Alone (CWP-DIANA-302)

JW Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Sitagliptin; Drug: Anagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01529541

CWP-DIANA-302

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Sitagliptin

Active Comparator group

Description:

Sitagliptin 100mg

Treatment:

Drug: Sitagliptin

CWP-0403

Experimental group

Description:

CWP-0403 100mg

Treatment:

Drug: Anagliptin