Diabetes Mellitus, Type 2
Conditions
Keywords
Hyperglycemia, HbA1c, Hemoglobin A1c, Type 2 diabetes mellitus
Brief summary
The purpose of this research study is to determine if a new investigational diabetes drug is safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood after an 8 hour fast.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Laboratory result for HbA1c \>11% or FPG \>270mg/dL * Clinical diagnosis of Type II diabetes * Prior treatment with diet and/or exercise alone, or less than 15 days of prior treatment with an oral anti-diabetic medication or insulin.
Exclusion criteria
* Women who are pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c (HbA1c) reduction after 24 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in FPG, insulin,C-peptide, insulin sensitivity,beta cell function, free fatty acids, lipids. Change in weight, vital signs, clinical laboratory tests, and adverse experiences. | — |
Countries
Australia, Canada, New Zealand, South Korea, United States
Outcome results
None listed