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Clinical Trial Details

Trial ID: L6616
Source ID: NCT01204593
Associated Drug: Insulin Glargine
Title: baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus
Acronym: SUBSTITUTE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: INSULIN GLARGINE|DRUG: INSULIN GLULISINE
Outcome Measures: Primary: 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: Change of HbA1c, from baseline to week 12|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)|Daily dose for insulin glulisine, At baseline, week 12 and week 24|Daily dose for insulin glargine, At baseline, week 12 and week 24|Symptomatic hypoglycemias, From baseline (week 0) to endpoint (week 24)
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT
Phases: PHASE4
Enrollment: 206
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-11
Completion Date: 2013-01
Results First Posted:
Last Update Posted: 2014-03-17
Locations: Investigational Site Number 01201, Algeries, Algeria|Investigational Site Number 01202, Algiers, Algeria|Investigational Site Number 01203, Algiers, Algeria|Investigational Site Number 01204, Algiers, Algeria|Investigational Site Number 03201, Caba, Argentina|Investigational Site Number 03202, Caba, Argentina|Investigational Site Number 03203, Caba, Argentina|Investigational Site Number 03204, Caba, Argentina|Investigational Site Number 03205, Morón, Argentina|Investigational Site Number 076-007, Curitiba, 80540-010, Brazil|Investigational Site Number 076-003, Distrito Federal, 71625-009, Brazil|Investigational Site Number 076-010, Fortaleza, 60430-370, Brazil|Investigational Site Number 076-006, Marília, 17519-101, Brazil|Investigational Site Number 076-004, Porto Alegre, 91350-250, Brazil|Investigational Site Number 076-002, São Paulo, 01244-030, Brazil|Investigational Site Number 17003, Barranquilla, Colombia|Investigational Site Number 17004, Bogotá, Colombia|Investigational Site Number 17005, Bogotá, Colombia|Investigational Site Number 17007, Bogotá, Colombia|Investigational Site Number 17006, Medellin, Colombia|Investigational Site Number 01, Kuwait, Kuwait|Investigational Site Number 48401, Guadalajara, 44600, Mexico|Investigational Site Number 48402, Guadalajara, 44656, Mexico|Investigational Site Number 48404, Guadalajara, 44680, Mexico|Investigational Site Number 48403, Monterrey, 64460, Mexico|Investigational Site Number 1, Riyadh, 11415, Saudi Arabia|Investigational Site Number 12468, Benoni, South Africa|Investigational Site Number 710004, Benoni, South Africa|Investigational Site Number 12466, Bloemfontein, 9301, South Africa|Investigational Site Number 710006, Bloemfontein, 9301, South Africa|Investigational Site Number 12464, Durban, 4091, South Africa|Investigational Site Number 12465, Durban, 4091, South Africa|Investigational Site Number 710001, Durban, 4091, South Africa|Investigational Site Number 710002, Durban, 4091, South Africa|Investigational Site Number 12484, Port Elizabeth, 6000, South Africa|Investigational Site Number 710003, Port Elizabeth, 6000, South Africa|Investigational Site Number 12467, Pretoria, South Africa|Investigational Site Number 710005, Pretoria, South Africa|Investigational Site Number 78801, Sfax, Tunisia|Investigational Site Number 78805, Sfax, Tunisia|Investigational Site Number 78803, Tunis, 1006, Tunisia|Investigational Site Number 78802, Tunis, Tunisia|Investigational Site Number 78804, Tunis, Tunisia
URL: https://clinicaltrials.gov/show/NCT01204593

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress