baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus (SUBSTITUTE)
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).
- 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
|Diabetes Mellitus, Type 1||Drug: INSULIN GLARGINE Drug: INSULIN GLULISINE||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase IV, Multicenter, International, Non-comparative, Open Label Study of Efficacy and Safety of Basal Bolus Therapy (Insulin Glargine + Insulin Glulisine) in Patients With T1 Diabetes Previously Uncontrolled on Any Insulin Regimen.|
- Change in hemoglobin A1c (HbA1c) values (following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)) [ Time Frame: between baseline (week 0) and endpoint (week 24) ]
- Change of HbA1c [ Time Frame: from baseline to week 12 ]
- Percentage of patients with HbA1c < 7% [ Time Frame: at week 12 and week 24 ]
- Fasting Blood Glucose (FBG) [ Time Frame: at baseline, week 12 and week 24 ]
- 7-point Self Monitoring of Blood Glucose (SMBG) [ Time Frame: at baseline, week 12 and week 24 (to be performed the week preceding each visit on two consecutive days) ]
- Daily dose for insulin glulisine [ Time Frame: At baseline, week 12 and week 24 ]
- Daily dose for insulin glargine [ Time Frame: At baseline, week 12 and week 24 ]
- Symptomatic hypoglycemias [ Time Frame: From baseline (week 0) to endpoint (week 24) ]
|Study Start Date:||November 2010|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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.
Drug: INSULIN GLARGINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day at bedtime
Other Name: Lantus SoloStarDrug: INSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: three times a day, preferably just before the meal
Other Name: Apidra SoloStar
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204593
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|Study Director:||Clinical Sciences & Operations||Sanofi|