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OpenTrials
Completed

NCT Number: NCT00238472

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nateglinide

Drug

Primary outcomes

  1. Change from baseline in postprandial glomerular filtration rate at 12 weeks

Secondary outcomes

  1. Change from baseline in fasting morning glomerular filtration rate at 12 weeks

  2. Change from baseline in postprandial renal plasma flow at 12 weeks

  3. Change from baseline in fasting morning renal plasma flow at 12 weeks

  4. Change from baseline in adjusted 2-hour postprandial glucose at 12 weeks

  5. Change in insulin AUC (0-240 minutes) at 12 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Oct 13, 2005
Registry last updated
Apr 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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