Diabetes Mellitus, Type 1
Conditions
Brief summary
Primary Objective: To evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day, tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Type 1 Diabetes Mellitus (T1DM). Secondary Objectives: To evaluate: * The change of hemoglobin A1c (HbA1c) from baseline to week 12 * The percentage of patients with HbA1c \< 7% at week 12 and week 24 * The FBG and the 7-point self monitoring of blood glucose (SMBG) at baseline, week 12 and week 24 * The daily dose for both insulin glulisine insulin glargine at baseline, week 12 and week 24 * The incidence of symptomatic hypoglycemias * Adverse events
Detailed description
After a two-week run-in period patients will enter a six-month treatment period. Estimated study duration per patient : 26 weeks (including a 2-week run-in period).
Interventions
DRUGINSULIN GLARGINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day at bedtime
DRUGINSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: three times a day, preferably just before the meal
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. Age: 18-60 years inclusive 3. HbA1c: 8% - 10% assessed over the past 6 month 4. At least 1 year of continuous insulin treatment 5. 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 6. Signed informed consent obtained prior to any study procedure Criteria for entry in the treatment period: 1. HbA1c 8-10% assessed between week -2 and week 0 2. Serum creatinine ≤135 micromol/L in men and ≤110 micromol/L in women 3. Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) lower or equal to three times the upper limit of normal 4. Pregnancy test negative if women of childbearing potential
Exclusion criteria
1. History of hypersensitivity to insulin glargine and/or insulin glulisine 2. Pregnant, breast-feeding or women of childbearing potential not using efficient contraception 3. Brittle diabetes 4. Known impaired renal function defined as serum creatinine \> 135 micromol/L in men and \> 110 micromol/L in women at study entry 5. 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 6. Diabetes ketoacidosis 7. History of drug or alcohol abuse 8. Psychiatric or mental disease 9. Inclusion in another study in the past 6 months or previous inclusion in this study 10. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hemoglobin A1c (HbA1c) values (following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)) | between baseline (week 0) and endpoint (week 24) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with HbA1c < 7% | at week 12 and week 24 |
| Fasting Blood Glucose (FBG) | at baseline, week 12 and week 24 |
| 7-point Self Monitoring of Blood Glucose (SMBG) | at baseline, week 12 and week 24 (to be performed the week preceding each visit on two consecutive days) |
| Change of HbA1c | from baseline to week 12 |
| Daily dose for insulin glargine | At baseline, week 12 and week 24 |
| Symptomatic hypoglycemias | From baseline (week 0) to endpoint (week 24) |
| Daily dose for insulin glulisine | At baseline, week 12 and week 24 |
Countries
Algeria, Argentina, Brazil, Colombia, Kuwait, Mexico, Saudi Arabia, South Africa, Tunisia
Outcome results
None listed