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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

nateglinide

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes, nateglinide

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

Outcomes

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

Full Information

NCT ID

NCT00238472

First Posted

October 12, 2005

Last Updated

April 25, 2012

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00238472

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

June 2005 (Actual)

Study Completion Date

June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes, nateglinide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

nateglinide

Primary Outcome Measure Information:

Title

Change from baseline in postprandial glomerular filtration rate at 12 weeks

Secondary Outcome Measure Information:

Title

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

Title

Change from baseline in postprandial renal plasma flow at 12 weeks

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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