baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus (SUBSTITUTE)
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion criteria:
Known Type 1 diabetic patients (male or female) treated with any type of insulin regimen, except:
- continuous subcutaneous insulin infusion (CSII, or pump), and
- patients already treated with insulin glargine
- Age: 18-60 years inclusive
- HbA1c: 8% - 10% assessed over the past 6 month
- At least 1 year of continuous insulin treatment
Willingness to accept, and ability to follow:
- a basal bolus regimen (glargine x1 and glulisine x3 per day),
- self-monitoring blood glucose (SMBG)
- a fixed meal plan, or CHO counting
- Signed informed consent obtained prior to any study procedure
Criteria for entry in the treatment period:
- HbA1c 8-10% assessed between week -2 and week 0
- Serum creatinine ≤135 micromol/L in men and ≤110 micromol/L in women
- Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) lower or equal to three times the upper limit of normal
- Pregnancy test negative if women of childbearing potential
Exclusion criteria:
- History of hypersensitivity to insulin glargine and/or insulin glulisine
- Pregnant, breast-feeding or women of childbearing potential not using efficient contraception
- Brittle diabetes
- Known impaired renal function defined as serum creatinine > 135 micromol/L in men and > 110 micromol/L in women at study entry
- Known impaired hepatic function defined as Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal at study entry
- Diabetes ketoacidosis
- History of drug or alcohol abuse
- Psychiatric or mental disease
- Inclusion in another study in the past 6 months or previous inclusion in this study
- Patient unable or unwilling to manage properly the basal bolus regimen
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number 01201
- Investigational Site Number 01202
- Investigational Site Number 01203
- Investigational Site Number 01204
- Investigational Site Number 03201
- Investigational Site Number 03202
- Investigational Site Number 03203
- Investigational Site Number 03204
- Investigational Site Number 03205
- Investigational Site Number 076-007
- Investigational Site Number 076-003
- Investigational Site Number 076-010
- Investigational Site Number 076-006
- Investigational Site Number 076-004
- Investigational Site Number 076-002
- Investigational Site Number 17003
- Investigational Site Number 17004
- Investigational Site Number 17005
- Investigational Site Number 17007
- Investigational Site Number 17006
- Investigational Site Number 01
- Investigational Site Number 48401
- Investigational Site Number 48402
- Investigational Site Number 48404
- Investigational Site Number 48403
- Investigational Site Number 1
- Investigational Site Number 12468
- Investigational Site Number 710004
- Investigational Site Number 12466
- Investigational Site Number 710006
- Investigational Site Number 12464
- Investigational Site Number 12465
- Investigational Site Number 710001
- Investigational Site Number 710002
- Investigational Site Number 12484
- Investigational Site Number 710003
- Investigational Site Number 12467
- Investigational Site Number 710005
- Investigational Site Number 78801
- Investigational Site Number 78805
- Investigational Site Number 78803
- Investigational Site Number 78802
- Investigational Site Number 78804
Arms of the Study
Arm 1
Experimental
Insulin glargine + insulin glulisine
Insulin glargine dosage will be individually titrated once a week to obtain FPG 80-120 mg/dL (4.5-6.7 mmol/L). Insulin glulisine dosage will be individually titrated once a week to obtain a 2-hour postprandial plasma glucose (PPG) < 180 mg/dL (<10.0 mmol/L) and ideally around 140 mg/dL.