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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00238472
• Collaborator: (none)
• Enrollment: 24
• Duration (Months): 25

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: nateglinide	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study to Evaluate the Effects of Nateglinide vs. Glibenclamide on Renal Hemodynamics and Albumin Excretion
• Study Start Date: May 1, 2003
• Actual Primary Completion Date: Jun 1, 2005
• Actual Study Completion Date: Jun 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All

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

Locations

No locations specified.

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00238472
• Other Study ID Numbers: CDJN608AIT05
• First Posted: Oct 13, 2005
• Last Update Posted: Apr 27, 2012
• Last Verified: Apr 1, 2012

• Keywords provided by Novartis Pharmaceuticals: Type 2 diabetes; nateglinide
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2; Nateglinide

Study Results

No Results Posted as of Apr 27, 2012