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

Novartis Pharmaceuticals24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

nateglinideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline in postprandial glomerular filtration rate at 12 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.