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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00238472
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-13
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-25
• Last Update Posted: 2012-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in postprandial glomerular filtration rate at 12 weeks

Secondary Outcome Measures

Name	Time	Method
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