A Pilot Study to Evaluate the Effects of Nateglinide Vs. Glibenclamide on Renal Hemodynamics and Albumin Excretion

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: nateglinide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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.

Official title: A Pilot Study to Evaluate the Effects of Nateglinide Vs. Glibenclamide on Renal Hemodynamics and Albumin Excretion

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Change from baseline in postprandial glomerular filtration rate at 12 weeks

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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 exclusion criteria may apply

Starting date: May 2003
Last updated: June 1, 2006