GW823093C For The Treatment Of Type 2 Diabetes Mellitus

August 30, 2018 updated by: GlaxoSmithKline

GW823093 Japan Phase IIa Mono

This study was designed to find dose response and as extension in treatment of GW823093C.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • GSK Investigational Site
  • Japan
      • Hokkaido, Japan, 051-0005
        • GSK Investigational Site
      • Miyagi, Japan, 985-0852
        • GSK Investigational Site
      • Tokyo, Japan, 160-0017
        • GSK Investigational Site
      • Tokyo, Japan, 130-0004
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Type 2 diabetes mellitus.
  • Managed by diet therapy or receiving treatment with oral anti-diabetic monotherapy (excluding TZD (Thiazolidinediones))

Exclusion criteria:

  • Patients who have metabolic disease judged by investigator as a clinically significance
  • Serious cardiovascular disease or serious hepatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: GW823093C A
A=45 mg
Drug: GW823093C A
A=45 mg
Placebo Comparator: GW823093C B
B=30 mg
Drug: GW823093C B
B=30 mg
Placebo Comparator: GW823093C C
C=15 mg
Drug: GW823093C C
C=25 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Long term safety variables
Time Frame: 64 weeks
64 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 25, 2006

Study Registration Dates

First Submitted

August 30, 2006

First Submitted That Met QC Criteria

August 30, 2006

First Posted (Estimate)

September 1, 2006

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 30, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPB106652

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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