baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus (SUBSTITUTE)
14. mars 2014 oppdatert 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
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Intervensjonell
Registrering (Faktiske)
206
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Algeries, Algerie
- Investigational Site Number 01201
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Algiers, Algerie
- Investigational Site Number 01202
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Algiers, Algerie
- Investigational Site Number 01203
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Algiers, Algerie
- 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, Brasil, 80540-010
- Investigational Site Number 076-007
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Distrito Federal, Brasil, 71625-009
- Investigational Site Number 076-003
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Fortaleza, Brasil, 60430-370
- Investigational Site Number 076-010
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Marília, Brasil, 17519-101
- Investigational Site Number 076-006
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Porto Alegre, Brasil, 91350-250
- Investigational Site Number 076-004
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São Paulo, Brasil, 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, Mexico, 44600
- Investigational Site Number 48401
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Guadalajara, Mexico, 44656
- Investigational Site Number 48402
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Guadalajara, Mexico, 44680
- Investigational Site Number 48404
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Monterrey, Mexico, 64460
- Investigational Site Number 48403
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Riyadh, Saudi-Arabia, 11415
- Investigational Site Number 1
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Benoni, Sør-Afrika
- Investigational Site Number 12468
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Benoni, Sør-Afrika
- Investigational Site Number 710004
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Bloemfontein, Sør-Afrika, 9301
- Investigational Site Number 12466
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Bloemfontein, Sør-Afrika, 9301
- Investigational Site Number 710006
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Durban, Sør-Afrika, 4091
- Investigational Site Number 710002
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Durban, Sør-Afrika, 4091
- Investigational Site Number 12464
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Durban, Sør-Afrika, 4091
- Investigational Site Number 12465
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Durban, Sør-Afrika, 4091
- Investigational Site Number 710001
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Port Elizabeth, Sør-Afrika, 6000
- Investigational Site Number 12484
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Port Elizabeth, Sør-Afrika, 6000
- Investigational Site Number 710003
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Pretoria, Sør-Afrika
- Investigational Site Number 12467
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Pretoria, Sør-Afrika
- Investigational Site Number 710005
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Sfax, Tunisia
- Investigational Site Number 78805
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Sfax, Tunisia
- Investigational Site Number 78801
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Tunis, Tunisia
- Investigational Site Number 78802
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Tunis, Tunisia, 1006
- Investigational Site Number 78803
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Tunis, Tunisia
- Investigational Site Number 78804
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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
Andre navn:
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: three times a day, preferably just before the meal
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Change in hemoglobin A1c (HbA1c) values (following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC))
Tidsramme: between baseline (week 0) and endpoint (week 24)
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between baseline (week 0) and endpoint (week 24)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Change of HbA1c
Tidsramme: from baseline to week 12
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from baseline to week 12
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Percentage of patients with HbA1c < 7%
Tidsramme: at week 12 and week 24
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at week 12 and week 24
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Fasting Blood Glucose (FBG)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: At baseline, week 12 and week 24
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At baseline, week 12 and week 24
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Symptomatic hypoglycemias
Tidsramme: From baseline (week 0) to endpoint (week 24)
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From baseline (week 0) to endpoint (week 24)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2010
Primær fullføring (Faktiske)
1. januar 2013
Studiet fullført (Faktiske)
1. januar 2013
Datoer for studieregistrering
Først innsendt
16. september 2010
Først innsendt som oppfylte QC-kriteriene
16. september 2010
Først lagt ut (Anslag)
17. september 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. mars 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. mars 2014
Sist bekreftet
1. mars 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LANTU_R_05033
- U1111-1116-3450 (Annen identifikator: WHO)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .