Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study (GLANS)

Sanofi

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 1

Treatments

Drug: insulin glulisine

Drug: insulin glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00539448

LANTU_L_01578

Details and patient eligibility

About

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.

Enrollment

98 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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