baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus (SUBSTITUTE)
14 mars 2014 uppdaterad av: Sanofi
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.
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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Interventionell
Inskrivning (Faktisk)
206
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Algeries, Algeriet
- Investigational Site Number 01201
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Algiers, Algeriet
- Investigational Site Number 01202
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Algiers, Algeriet
- Investigational Site Number 01203
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Algiers, Algeriet
- Investigational Site Number 01204
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Caba, Argentina
- Investigational Site Number 03201
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Caba, Argentina
- Investigational Site Number 03202
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Caba, Argentina
- Investigational Site Number 03203
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Caba, Argentina
- Investigational Site Number 03204
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Morón, Argentina
- Investigational Site Number 03205
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Curitiba, Brasilien, 80540-010
- Investigational Site Number 076-007
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Distrito Federal, Brasilien, 71625-009
- Investigational Site Number 076-003
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Fortaleza, Brasilien, 60430-370
- Investigational Site Number 076-010
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Marília, Brasilien, 17519-101
- Investigational Site Number 076-006
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Porto Alegre, Brasilien, 91350-250
- Investigational Site Number 076-004
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São Paulo, Brasilien, 01244-030
- Investigational Site Number 076-002
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Barranquilla, Colombia
- Investigational Site Number 17003
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Bogotá, Colombia
- Investigational Site Number 17004
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Bogotá, Colombia
- Investigational Site Number 17005
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Bogotá, Colombia
- Investigational Site Number 17007
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Medellin, Colombia
- Investigational Site Number 17006
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Kuwait, Kuwait
- Investigational Site Number 01
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Guadalajara, Mexiko, 44600
- Investigational Site Number 48401
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Guadalajara, Mexiko, 44656
- Investigational Site Number 48402
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Guadalajara, Mexiko, 44680
- Investigational Site Number 48404
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Monterrey, Mexiko, 64460
- Investigational Site Number 48403
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Riyadh, Saudiarabien, 11415
- Investigational Site Number 1
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Benoni, Sydafrika
- Investigational Site Number 12468
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Benoni, Sydafrika
- Investigational Site Number 710004
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Bloemfontein, Sydafrika, 9301
- Investigational Site Number 12466
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Bloemfontein, Sydafrika, 9301
- Investigational Site Number 710006
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Durban, Sydafrika, 4091
- Investigational Site Number 710002
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Durban, Sydafrika, 4091
- Investigational Site Number 12464
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Durban, Sydafrika, 4091
- Investigational Site Number 12465
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Durban, Sydafrika, 4091
- Investigational Site Number 710001
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Port Elizabeth, Sydafrika, 6000
- Investigational Site Number 12484
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Port Elizabeth, Sydafrika, 6000
- Investigational Site Number 710003
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Pretoria, Sydafrika
- Investigational Site Number 12467
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Pretoria, Sydafrika
- Investigational Site Number 710005
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Sfax, Tunisien
- Investigational Site Number 78805
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Sfax, Tunisien
- Investigational Site Number 78801
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Tunis, Tunisien
- Investigational Site Number 78802
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Tunis, Tunisien, 1006
- Investigational Site Number 78803
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Tunis, Tunisien
- Investigational Site Number 78804
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 60 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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. |
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day at bedtime
Andra namn:
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: three times a day, preferably just before the meal
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Change in hemoglobin A1c (HbA1c) values (following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC))
Tidsram: between baseline (week 0) and endpoint (week 24)
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between baseline (week 0) and endpoint (week 24)
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Change of HbA1c
Tidsram: from baseline to week 12
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from baseline to week 12
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Percentage of patients with HbA1c < 7%
Tidsram: at week 12 and week 24
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at week 12 and week 24
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Fasting Blood Glucose (FBG)
Tidsram: at baseline, week 12 and week 24
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at baseline, week 12 and week 24
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7-point Self Monitoring of Blood Glucose (SMBG)
Tidsram: at baseline, week 12 and week 24 (to be performed the week preceding each visit on two consecutive days)
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at baseline, week 12 and week 24 (to be performed the week preceding each visit on two consecutive days)
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Daily dose for insulin glulisine
Tidsram: At baseline, week 12 and week 24
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At baseline, week 12 and week 24
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Daily dose for insulin glargine
Tidsram: At baseline, week 12 and week 24
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At baseline, week 12 and week 24
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Symptomatic hypoglycemias
Tidsram: From baseline (week 0) to endpoint (week 24)
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From baseline (week 0) to endpoint (week 24)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2010
Primärt slutförande (Faktisk)
1 januari 2013
Avslutad studie (Faktisk)
1 januari 2013
Studieregistreringsdatum
Först inskickad
16 september 2010
Först inskickad som uppfyllde QC-kriterierna
16 september 2010
Första postat (Uppskatta)
17 september 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
17 mars 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 mars 2014
Senast verifierad
1 mars 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LANTU_R_05033
- U1111-1116-3450 (Annan identifierare: WHO)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .