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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00238472
First received: October 12, 2005
Last updated: April 25, 2012
Last verified: April 2012
  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 4

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:


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
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  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 Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00238472     History of Changes
Other Study ID Numbers: CDJN608AIT05
Study First Received: October 12, 2005
Last Updated: April 25, 2012
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 April 17, 2014