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

This study has been completed.

First Received on October 12, 2005. Last Updated on June 1, 2006 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00238472

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: nateglinide	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Pilot Study to Evaluate the Effects of Nateglinide Vs. Glibenclamide on Renal Hemodynamics and Albumin Excretion

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Glyburide A 4166

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in postprandial glomerular filtration rate at 12 weeks

Secondary Outcome Measures:

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

Estimated Enrollment:	24
Study Start Date:	May 2003

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238472

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00238472 History of Changes
Other Study ID Numbers:	CDJN608AIT05
Study First Received:	October 12, 2005
Last Updated:	June 1, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Type 2 diabetes
nateglinide

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Nateglinide
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012