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baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus (SUBSTITUTE)

14. marts 2014 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

206

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Algeriet
      • Algeries, Algeriet
        • Investigational Site Number 01201
      • Algiers, Algeriet
        • Investigational Site Number 01202
      • Algiers, Algeriet
        • Investigational Site Number 01203
      • Algiers, Algeriet
        • Investigational Site Number 01204
  • Argentina
      • Caba, Argentina
        • Investigational Site Number 03201
      • Caba, Argentina
        • Investigational Site Number 03202
      • Caba, Argentina
        • Investigational Site Number 03203
      • Caba, Argentina
        • Investigational Site Number 03204
      • Morón, Argentina
        • Investigational Site Number 03205
  • Brasilien
      • Curitiba, Brasilien, 80540-010
        • Investigational Site Number 076-007
      • Distrito Federal, Brasilien, 71625-009
        • Investigational Site Number 076-003
      • Fortaleza, Brasilien, 60430-370
        • Investigational Site Number 076-010
      • Marília, Brasilien, 17519-101
        • Investigational Site Number 076-006
      • Porto Alegre, Brasilien, 91350-250
        • Investigational Site Number 076-004
      • São Paulo, Brasilien, 01244-030
        • Investigational Site Number 076-002
  • Colombia
      • Barranquilla, Colombia
        • Investigational Site Number 17003
      • Bogotá, Colombia
        • Investigational Site Number 17004
      • Bogotá, Colombia
        • Investigational Site Number 17005
      • Bogotá, Colombia
        • Investigational Site Number 17007
      • Medellin, Colombia
        • Investigational Site Number 17006
  • Kuwait
      • Kuwait, Kuwait
        • Investigational Site Number 01
  • Mexico
      • Guadalajara, Mexico, 44600
        • Investigational Site Number 48401
      • Guadalajara, Mexico, 44656
        • Investigational Site Number 48402
      • Guadalajara, Mexico, 44680
        • Investigational Site Number 48404
      • Monterrey, Mexico, 64460
        • Investigational Site Number 48403
  • Saudi Arabien
      • Riyadh, Saudi Arabien, 11415
        • Investigational Site Number 1
  • Sydafrika
      • Benoni, Sydafrika
        • Investigational Site Number 12468
      • Benoni, Sydafrika
        • Investigational Site Number 710004
      • Bloemfontein, Sydafrika, 9301
        • Investigational Site Number 12466
      • Bloemfontein, Sydafrika, 9301
        • Investigational Site Number 710006
      • Durban, Sydafrika, 4091
        • Investigational Site Number 710002
      • Durban, Sydafrika, 4091
        • Investigational Site Number 12464
      • Durban, Sydafrika, 4091
        • Investigational Site Number 12465
      • Durban, Sydafrika, 4091
        • Investigational Site Number 710001
      • Port Elizabeth, Sydafrika, 6000
        • Investigational Site Number 12484
      • Port Elizabeth, Sydafrika, 6000
        • Investigational Site Number 710003
      • Pretoria, Sydafrika
        • Investigational Site Number 12467
      • Pretoria, Sydafrika
        • Investigational Site Number 710005
  • Tunesien
      • Sfax, Tunesien
        • Investigational Site Number 78805
      • Sfax, Tunesien
        • Investigational Site Number 78801
      • Tunis, Tunesien
        • Investigational Site Number 78802
      • Tunis, Tunesien, 1006
        • Investigational Site Number 78803
      • Tunis, Tunesien
        • Investigational Site Number 78804

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  1. 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
  2. Age: 18-60 years inclusive
  3. HbA1c: 8% - 10% assessed over the past 6 month
  4. At least 1 year of continuous insulin treatment

  5. 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
  6. Signed informed consent obtained prior to any study procedure

Criteria for entry in the treatment period:

  1. HbA1c 8-10% assessed between week -2 and week 0
  2. Serum creatinine ≤135 micromol/L in men and ≤110 micromol/L in women
  3. Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) lower or equal to three times the upper limit of normal
  4. Pregnancy test negative if women of childbearing potential

Exclusion criteria:

  1. History of hypersensitivity to insulin glargine and/or insulin glulisine
  2. Pregnant, breast-feeding or women of childbearing potential not using efficient contraception
  3. Brittle diabetes
  4. Known impaired renal function defined as serum creatinine > 135 micromol/L in men and > 110 micromol/L in women at study entry
  5. 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
  6. Diabetes ketoacidosis
  7. History of drug or alcohol abuse
  8. Psychiatric or mental disease
  9. Inclusion in another study in the past 6 months or previous inclusion in this study
  10. 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: INSULIN GLARGINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day at bedtime
Andre navne:
  • Lantus SoloStar
Medicin: INSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: three times a day, preferably just before the meal
Andre navne:
  • Apidra SoloStar

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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)
between baseline (week 0) and endpoint (week 24)

Sekundære resultatmål

Resultatmål
Tidsramme
Change of HbA1c
Tidsramme: from baseline to week 12
from baseline to week 12
Percentage of patients with HbA1c < 7%
Tidsramme: at week 12 and week 24
at week 12 and week 24
Fasting Blood Glucose (FBG)
Tidsramme: at baseline, week 12 and week 24
at baseline, week 12 and week 24
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)
at baseline, week 12 and week 24 (to be performed the week preceding each visit on two consecutive days)
Daily dose for insulin glulisine
Tidsramme: At baseline, week 12 and week 24
At baseline, week 12 and week 24
Daily dose for insulin glargine
Tidsramme: At baseline, week 12 and week 24
At baseline, week 12 and week 24
Symptomatic hypoglycemias
Tidsramme: From baseline (week 0) to endpoint (week 24)
From baseline (week 0) to endpoint (week 24)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanofi

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2010

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først indsendt

16. september 2010

Først indsendt, der opfyldte QC-kriterier

16. september 2010

Først opslået (Skøn)

17. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. marts 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. marts 2014

Sidst verificeret

1. marts 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LANTU_R_05033
  • U1111-1116-3450 (Anden identifikator: WHO)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetes mellitus, type 1

Kliniske forsøg med INSULIN GLARGINE

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Pakistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner