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 weeksChange 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
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