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Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus

NCT00964574 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2012-07-17

No results posted yet for this study

Summary

Primary Objective:

To evaluate the efficacy and the safety of insulin glulisine in type I Diabetes Melittus (DM) patients

Secondary Objective:

To evaluate the insulin glulisine doses To assess the patient satisfaction

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

INSULIN GLULISINE (HMR1964)

Pharmaceutical form: APIDRA 100U/ml flacon for the titration period in the hospital APIDRA 100U/ml solution for injection in cartridge in OptiSet Route of administration: 3-4 subcutaneous injections per day

DRUG

INSULIN GLARGINE

Pharmaceutical form: LANTUS 100U/ml solution for injection in cartridge Route of administration: Once daily subcutaneous injection in the evening

Sponsors & Collaborators

Principal Investigators

  • Natallia Zhyhaila · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Belarus

Study Locations

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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 NCT00964574 on ClinicalTrials.gov