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

JW Pharmaceutical117 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

117

Conditions

Type 2 Diabetes Mellitus

Interventions

AnagliptinDRUG

Anagliptin 100mg, tablet, BID

AnagliptinDRUG

Anagliptin 100mg, tablet, BID

Placebo of AnagliptinDRUG

Placebo of Anagliptin 100mg, tablet, BID

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Kangbuk Samsung Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

The Change in HbA1c from baseline to week24

Time frame: 0wk, 8wk, 16wk, 24wk

Secondary Outcomes

The proportion of subjects achieving HbA1c<6.5% at week24

Time frame: 0wk, 8wk, 16wk, 24wk

The proportion of subjects achieving HbA1c<7% at week24

Time frame: 0wk, 8wk, 16wk, 24wk

The change from baseline to week 24: Fasting plasma glucose

Time frame: 0wk, 24wk

change from baseline to week 24 in Fasting serum insulin

Time frame: 0 wk, 24 wk

change from baseline to week 24 in Fasting serum pro-insulin

Time frame: 0 wk, 24wk

change in from baseline to week 24 fasting serum c-peptide

Time frame: 0wk, 24wk

change from baseline to week 24 in HOMA-β

Time frame: owjm 24wk

change from baseline to week 24 in HOMA-IR

Time frame: 0wk, 24 wk

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.