Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes, nateglinide
Brief summary
This study is not being conducted in the United States. The purpose of the study is to evaluate the effects of nateglinide compared to glibenclamide on renal hemodynamics and albumin excretion.
Interventions
DRUGnateglinide
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Inclusion criteria
* Type 2 diabetes diagnosed at least 1 year before inclusion * Blood glucose criteria must be met * Microalbuminuria criteria must be met
Exclusion criteria
* Pregnant or nursing females or females of childbearing potential not using a medically approved birth control method * Blood glucose criteria outside the specified range * Microalbuminuria criteria outside the specified range * Serious cardiovascular events within the past 6 months * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in postprandial glomerular filtration rate at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting morning glomerular filtration rate at 12 weeks | — |
| Change from baseline in postprandial renal plasma flow at 12 weeks | — |
| Change from baseline in fasting morning renal plasma flow at 12 weeks | — |
| Change from baseline in adjusted 2-hour postprandial glucose at 12 weeks | — |
| Change in insulin AUC (0-240 minutes) at 12 weeks | — |
Outcome results
None listed