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

Novartis

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: nateglinide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00238472

CDJN608AIT05

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)