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Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study

NCT00539448 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2009-09-25

No results posted yet for this study

Summary

Primary objective :

To evaluate the efficacy (in terms of change in HbA1c readings starting from baseline then after 13 weeks \& at the end of the study which will be after 26 weeks) in subjects with type I diabetes mellitus.

Secondary objective :

* Recording the average daily dose of both insulin Glulisine \& insulin Glargine in type I DM.
* Recording adverse events.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

insulin glargine

in combination with insulin Glulisine as bolus regimen

DRUG

insulin glulisine

in combination with insulin Glargine as bolus regimen

Sponsors & Collaborators

Principal Investigators

  • Hisham - MAHMOUD, MD · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Bahrain
  • Kuwait
  • Qatar
  • United Arab Emirates

Study Locations

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 NCT00539448 on ClinicalTrials.gov