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GW823093C For The Treatment Of Type 2 Diabetes Mellitus

GW823093 Japan Phase IIa Mono

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00370942
Enrollment
159
Registered
2006-09-01
Start date
2006-04-01
Completion date
2006-11-25
Last updated
2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

GW823093C, diabetes, type 2 diabetes mellitus, DPP-IV inhibitor

Brief summary

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

Interventions

DRUGGW823093C A

A=45 mg

DRUGGW823093C B

B=30 mg

DRUGGW823093C C

C=25 mg

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group12 weeks

Secondary

MeasureTime frame
Long term safety variables64 weeks

Countries

Japan

Outcome results

None listed

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