Insulin Glulisine in Healthy Lean and Obese Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Insulin Glulisine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Systemic concomitant medication

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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sanofi-aventis

Principal Investigators

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Valérie Pilorget, MD

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

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HMR1964A_1502

Identifier Type: -

Identifier Source: org_study_id