DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: nateglinide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis Pharmaceuticals

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

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Eligibility

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

Locations and Contacts

Additional Information

Starting date: May 2003
Last updated: April 25, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017