Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study

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

PHASE4

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

combination of insulin Glargine \& insulin Glulisine as basal bolus regimen

Group Type EXPERIMENTAL

insulin glargine

Intervention Type DRUG

in combination with insulin Glulisine as bolus regimen

insulin glulisine

Intervention Type DRUG

in combination with insulin Glargine as bolus regimen

Interventions

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insulin glargine

in combination with insulin Glulisine as bolus regimen

Intervention Type DRUG

insulin glulisine

in combination with insulin Glargine as bolus regimen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed type I diabetic patients
* Type I diabetes treated with basal-bolus regimen including 3 or more injections of Regular Human Insulin per day
* BMI, 26-40 kg/m2
* HbA1c, 7.5%-10%
* Median 2Hrs post -prandial more than or equal to 140 mg/dl (more than or equal to 7.8 mmol/L)
* FPG more than or equal to 120 mg/dl (more than or equal to 6.7 mmol/L)
* Willingness to accept, and ability to inject insulin Glargine therapy

Exclusion Criteria

* Pregnancy : The use of LANTUS \& APIDRA during pregnancy is not contraindicated. However, in the absence of supportive data, Sanofi- Aventis Pharmaceuticals cannot specifically recommend the use of Lantus in this patient population

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No