A Study to Efficacy and Safety of CWP-0403 in Type 2 Diabetes Mellitus Patients (CWP-DIANA-301)

JW Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Anagliptin; Drug: Placebo of Anagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01529528

CWP-DIANA-301

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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117 participants in 3 patient groups, including a placebo group

Placebo of CWP-0403 100mg

Placebo Comparator group

Description:

Placebo of CWP-0403 100mg

Treatment:

Drug: Placebo of Anagliptin

CWP-0403 200mg

Experimental group

Description:

CWP-0403 200mg

Treatment:

Drug: Anagliptin

Drug: Anagliptin

CWP-0403 100mg

Experimental group

Description:

CWP-0403 100mg

Treatment:

Drug: Anagliptin

Drug: Anagliptin