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

NCT ID: NCT00238472

Last Updated: 2012-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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nateglinide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

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CDJN608AIT05

Identifier Type: -

Identifier Source: org_study_id

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