A Pilot Study to Evaluate the Effects of Nateglinide vs.... | NCT00238472

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

NCT00238472

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Apr 27, 2012Estimated

Enrollment

Phase

Phase 4

Conditions

Diabetes Mellitus, Type 2

Interventions

nateglinide

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

May 2003

Primary Completion Date

Jun 2005Actual

Completion Date

Jun 2005Actual

First Submitted Date

Oct 12, 2005

First Submission Date that Met QC Criteria

Oct 12, 2005

First Posted Date

Oct 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2012

Last Update Posted Date

Apr 27, 2012Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
nateglinide	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in postprandial glomerular filtration rate at 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077715	Nateglinide

Ancestor Terms

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided