baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus (SUBSTITUTE)
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|ClinicalTrials.gov Identifier: NCT01204593|
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : March 17, 2014
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
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Drug: INSULIN GLARGINE Drug: INSULIN GLULISINE||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||206 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
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 SoloStar
Drug: 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
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204593
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|Study Director:||Clinical Sciences & Operations||Sanofi|