MedTrace Logo

Insulin Glulisine in Type 1 Diabetes Mellitus

NCT00297583 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2009-12-07

No results posted yet for this study

Summary

The primary objective of the study was to compare the effect of insulin glulisine, insulin lispro and unmodified human insulin on endogenous glucose production during euglycemic glucose clamps using stable labeled glucose in type 1 diabetic subjects.

The secondary objectives of the study were to assess:

* the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma nonesterified free fatty acids (NEFA) and glycerol levels
* the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma lactate levels
* the safety and tolerability of insulin glulisine in comparison to insulin lispro and unmodified human insulin.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Insulin Glulisine

Sponsors & Collaborators

Principal Investigators

  • Valérie Pilorget · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2004-05-31

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00297583 on ClinicalTrials.gov