NCT00238472

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started May 2003

Typical duration for phase_4 diabetes-mellitus-type-2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

2.1 years

First QC Date

October 12, 2005

Last Update Submit

April 25, 2012

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetesnateglinide

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in postprandial glomerular filtration rate at 12 weeks

Secondary Outcomes (5)

  • 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

Interventions

nateglinideDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Blood glucose criteria must be met
  • Microalbuminuria criteria must be met

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Nateglinide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 13, 2005

Study Start

May 1, 2003

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

April 27, 2012

Record last verified: 2012-04