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

A Multicenter, Randomized, Double Blind, Placebo Controlled, Therapeutic Confirmatory Trial(Phase 3) to Evaluate Efficacy and Safety of CWP-0403 in Type 2 DM Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01529528

Acronym

CWP-DIANA-301

Enrollment

117

Registered

2012-02-09

Start date

2011-05-31

Completion date

2012-11-30

Last updated

2013-01-04

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, type 2 DM, Efficacy, Safety, Phase 3

Brief summary

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.

Interventions

DRUGAnagliptin

Anagliptin 100mg, tablet, BID

DRUGPlacebo of Anagliptin

Placebo of Anagliptin 100mg, tablet, BID

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

* 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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

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