SAM - Skip a Meal - Insulin Glargine, Diabetes Mellitus Type 1
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria: Patients with type 1 Diabetes mellitus who have been treated with MDI (Multiple Daily Injection) basal/bolus insulin, regular insulin/short acting insulin analogue + NPH insulin on a stable dose (no change more than 10 %) for at least 4 weeks prior to study entry, who have an HBA1c smaller/equal 9 % (measured at visit 1) and a BMI smaller/equal 35 kg/m2. In addition, patients must have a FBG value at day 1 before skipping meal (6:00 am - 07:00 am) between 90 - 120 mg/dl (5.0 - 6.5 mmol/l). Exclusion Criteria: Breast-feeding History of hypersensitivity to the study medication or to drugs with similar chemical structures Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol Treatment with any investigational drug in the last 30 days before study entry Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult History of drug or alcohol abuse No subjects who have previously been treated with Insulin glargine will be enrolled in this study.
Sites / Locations
- Sanofi-Aventis