NCT00311077

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.

Trial Health

100
On Track

Trial Health Score

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

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2006

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
Last Updated

December 7, 2009

Status Verified

December 1, 2009

Enrollment Period

6 months

First QC Date

March 2, 2006

Last Update Submit

December 4, 2009

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • To evaluate the serum insulin glulisine concentration and insulin lispro concentration

    During the Study Conduct

Secondary Outcomes (4)

  • To measure blood glucose

    During the study conduct

  • To measure glucose infusion rate

    During the study conduct

  • To measure the serum C-peptide

    During the study conduct

  • Adverse events collection

    from the inform consent signed up to the end of the study

Interventions

Insulin GlulisineDRUG

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Systemic concomitant medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin glulisine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Valérie Pilorget, MD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 2, 2006

First Posted

April 5, 2006

Study Start

April 1, 2004

Primary Completion

October 1, 2004

Last Updated

December 7, 2009

Record last verified: 2009-12