Insulin Glulisine in Healthy Lean and Obese Subjects | NCT00311077

Studies
Insulin Glulisine in Healthy Lean and Obese Subjects

NCT00311077

Sponsor

Sanofi

Status

Completed

Last Update Posted

Dec 7, 2009Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Diabetes Mellitus

Interventions

Insulin Glulisine

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

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004

Primary Completion Date

Oct 2004Actual

Completion Date

Not provided

First Submitted Date

Mar 2, 2006

First Submission Date that Met QC Criteria

Apr 3, 2006

First Posted Date

Apr 5, 2006Estimated

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

Dec 4, 2009

Last Update Posted Date

Dec 7, 2009Estimated

Description Module

Brief Summary

Primary objective

To investigate pharmacodynamic and pharmacokinetic parameters after s.c. administration of two different doses (low dose, 0.2 IU/kg and high dose, 0.4 IU/kg) of insulin glulisine across healthy subjects in 4 different BMI-classes (lean, overweight, moderately obese, severely obese), using the euglycemic clamp technique with the Biostator™.

Secondary objective

To investigate the pharmacodynamic and pharmacokinetic properties after subcutaneous administration of insulin glulisine in comparison to insulin lispro and to investigate the safety and tolerability after subcutaneous administration of insulin glulisine in comparison to insulin lispro.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Insulin Glulisine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the serum insulin glulisine concentration and insulin lispro concentration		During the Study Conduct

Secondary Outcomes

Measure	Description	Time Frame
To measure blood glucose		During the study conduct
To measure glucose infusion rate		During the study conduct
To measure the serum C-peptide

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria :

Normal HbA1c
Women have to either be postmenopausal, surgically sterilized, or not pregnant and using adequate contraception.

Exclusion criteria :

Systemic concomitant medication

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Valérie Pilorget, MD	Sanofi	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C479079	insulin glulisine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided