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Efficacy Study on the Control of Blood Glucose Concentration in Type 1 Diabetic Patients

NCT00271284 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2009-12-07

No results posted yet for this study

Summary

·Main objective: To compare the variability of fasting capillary blood glucose concentration, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics. It is a non-inferiority study.

·Secondary objectives:

Efficacy:

* To compare the variability of blood glucose concentration before the evening meal, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics.
* To record the intra- and inter-daily variability using the MAGE and MODD indices \[1,2,3,4\]
* To compare the glycaemic profiles (7 points)
* To evaluate the HbA1c concentration, at the end of each period of treatment, weight change, the dose of insulin used and the number of daily injections.

Tolerance:

* To record undesirable events
* To evaluate the safety in use from the record of episodes of hypoglycaemia (symptomatic, diurnal, nocturnal, severe).

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

insulin glulisine / insulin glargine

insulin glargine administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00

DRUG

insulin glulisin / insulin detemir

insulin detemir administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00

Sponsors & Collaborators

Principal Investigators

  • Marie SEBILLE, Dr · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • France

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 NCT00271284 on ClinicalTrials.gov