Diabetes Mellitus, Type 2
Conditions
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
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
| Measure | Time frame |
|---|---|
| Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Long term safety variables | 64 weeks |
Countries
Japan
Outcome results
None listed