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Dose-ranging Study in Patients With Type 1 Diabetes Mellitus (inTandem4)

10. februar 2020 opdateret af: Lexicon Pharmaceuticals

A Phase 2b, Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study in Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

The primary objective of this study was to define the dose leading to desirable efficacy, as measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

141

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Concord, California, Forenede Stater, 94520
        • Lexicon Investigational Site
      • Ventura, California, Forenede Stater, 93003
        • Lexicon Investigational Site
    • Colorado
      • Denver, Colorado, Forenede Stater, 80209
        • Lexicon Investigational Site
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32225
        • Lexicon Investigational Site
      • Miami, Florida, Forenede Stater, 33175
        • Lexicon Investigational Site
    • Illinois
      • Springfield, Illinois, Forenede Stater, 62711
        • Lexicon Investigational Site
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70006
        • Lexicon Investigational Site
    • Maine
      • Auburn, Maine, Forenede Stater, 04210
        • Lexicon Investigational Site
    • Maryland
      • Rockville, Maryland, Forenede Stater, 20852
        • Lexicon Investigational Site
    • Montana
      • Great Falls, Montana, Forenede Stater, 59405
        • Lexicon Investigational Site
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68114
        • Lexicon Investigational Site
    • North Carolina
      • High Point, North Carolina, Forenede Stater, 27265
        • Lexicon Investigational Site
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43213
        • Lexicon Investigational Site
    • Texas
      • San Antonio, Texas, Forenede Stater, 78229
        • Lexicon Investigational Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84107
        • Lexicon Investigational Site
    • Virginia
      • Chesapeake, Virginia, Forenede Stater, 23321
        • Lexicon Investigational Site
      • Manassas, Virginia, Forenede Stater, 20110
        • Lexicon Investigational Site

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Participant had given written informed consent to participate in the study in accordance with local regulations.
  • Adult participants 18 years and older with a diagnosis of type 1 diabetes mellitus (T1D) made at least 1 year prior to informed consent.
  • Participants were being treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injection (MDI).
  • At the Screening Visit, A1C had to be between 7.0% and 10.0%.
  • Females of childbearing potential had to use an adequate method of contraception and have a negative pregnancy test.

Exclusion Criteria:

  • Use of antidiabetic agent other than insulin or insulin analog at the time of screening.
  • Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening.
  • Chronic systemic corticosteroid use.
  • Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
Medicin: Placebo
Placebo én gang dagligt før dagens første måltid
Eksperimentel: Sotagliflozin 75 mg
Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally for 12 weeks.
Medicin: Placebo
Placebo én gang dagligt før dagens første måltid
Medicin: Sotagliflozin
Sotagliflozin,once daily, before the first meal of the day
Eksperimentel: Sotagliflozin 200 mg
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally for 12 weeks.
Medicin: Placebo
Placebo én gang dagligt før dagens første måltid
Medicin: Sotagliflozin
Sotagliflozin,once daily, before the first meal of the day
Eksperimentel: Sotagliflozin 400 mg
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally for 12 weeks.
Medicin: Sotagliflozin
Sotagliflozin,once daily, before the first meal of the day

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Hemoglobin A1C (A1C) at Week 12
Tidsramme: Baseline to Week 12
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-baseline Least Square (LS) mean values were obtained from mixed-effects model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery method (continuous subcutaneous insulin infusion [CSII] or multiple daily injection [MDI]), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.
Baseline to Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal
Tidsramme: Baseline, Week 12
A 2-hour PPG sample (plasma) was obtained 2-hours after a standardized Mixed Meal at Baseline (Day 1) and at the visit at Week 12. Post-Baseline LS mean was obtained from analysis of covariance (ANCOVA) model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and baseline postprandial glucose as a covariate.
Baseline, Week 12
Absolute Change From Baseline in Body Weight to Week 12
Tidsramme: Baseline to Week 12
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate.
Baseline to Week 12
Percent Change From Baseline in Body Weight to Week 12
Tidsramme: Baseline to Week 12
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate.
Baseline to Week 12
Change From Baseline to Week 12 in 24-Hour Urinary Glucose Excretion
Tidsramme: Baseline, Week 12
Urine was collected over 24 hours to measure Urinary Glucose Excretion at baseline, and at the end of the 12-week treatment. Post-Baseline LS mean was obtained from ANCOVA model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and Baseline urinary glucose excretion as a covariate.
Baseline, Week 12
Change From Baseline to Week 12 in Fasting Plasma Glucose
Tidsramme: Baseline to Week 12
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline fasting plasma glucose-by-time interaction as a covariate.
Baseline to Week 12

Samarbejdspartnere og efterforskere

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

Sponsor

Lexicon Pharmaceuticals

Samarbejdspartnere

Sanofi

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

1. juli 2015

Primær færdiggørelse (Faktiske)

1. august 2016

Studieafslutning (Faktiske)

1. august 2016

Datoer for studieregistrering

Først indsendt

29. maj 2015

Først indsendt, der opfyldte QC-kriterier

1. juni 2015

Først opslået (Skøn)

2. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LX4211.1-206-T1DM
  • LX4211.206 (Anden identifikator: Lexicon Pharmaceuticals, Inc.)

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 Type 1 diabetes mellitus

Kliniske forsøg med Placebo

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