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

NCT ID: NCT01529528

Last Updated: 2013-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo of CWP-0403 100mg

Placebo of CWP-0403 100mg

Group Type PLACEBO_COMPARATOR

Placebo of Anagliptin

Intervention Type DRUG

Placebo of Anagliptin 100mg, tablet, BID

CWP-0403 200mg

CWP-0403 200mg

Group Type EXPERIMENTAL

Anagliptin

Intervention Type DRUG

Anagliptin 100mg, tablet, BID

CWP-0403 100mg

CWP-0403 100mg

Group Type EXPERIMENTAL

Anagliptin

Intervention Type DRUG

Anagliptin 100mg, tablet, BID

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anagliptin

Anagliptin 100mg, tablet, BID

Intervention Type DRUG

Anagliptin

Anagliptin 100mg, tablet, BID

Intervention Type DRUG

Placebo of Anagliptin

Placebo of Anagliptin 100mg, tablet, BID

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

JW Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sung Woo Park, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CWP-DIANA-301

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study In People With Type 2 Diabetes
NCT00196989 COMPLETED PHASE2