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NCT00370942 Clinical Trial

GW823093C For The Treatment Of Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
GW823093 Japan Phase IIa Mono

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00370942
Other study ID # DPB106652
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date April 1, 2006
Est. completion date November 25, 2006

Study information
Verified date August 2018
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 159
Est. completion date November 25, 2006
Est. primary completion date November 1, 2006
Accepts healthy volunteers No
Gender All
Age group 20 Years to 74 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• GW823093C A
A=45 mg
• GW823093C B
B=30 mg
• GW823093C C
C=25 mg

Locations
Country Name City State
GSK Investigational Site
Japan GSK Investigational Site Hokkaido
Japan GSK Investigational Site Miyagi
Japan GSK Investigational Site Tokyo
Japan GSK Investigational Site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group 12 weeks
Secondary Long term safety variables 64 weeks
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