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A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin

24. januar 2017 opdateret af: Novo Nordisk A/S
This trial is conducted in the United States of America (USA). The aim of the trial is to confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

145

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Arizona
      • Mesa, Arizona, Forenede Stater, 85206
        • Novo Nordisk Investigational Site
    • California
      • Fresno, California, Forenede Stater, 93720
        • Novo Nordisk Investigational Site
      • Greenbrae, California, Forenede Stater, 94904
        • Novo Nordisk Investigational Site
      • San Ramon, California, Forenede Stater, 94583
        • Novo Nordisk Investigational Site
    • Florida
      • Bradenton, Florida, Forenede Stater, 34201
        • Novo Nordisk Investigational Site
      • Hialeah, Florida, Forenede Stater, 33012
        • Novo Nordisk Investigational Site
      • Homestead, Florida, Forenede Stater, 33030
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, Forenede Stater, 32207
        • Novo Nordisk Investigational Site
      • Kissimmee, Florida, Forenede Stater, 34741
        • Novo Nordisk Investigational Site
      • Miami, Florida, Forenede Stater, 33156
        • Novo Nordisk Investigational Site
      • Miami, Florida, Forenede Stater, 33155
        • Novo Nordisk Investigational Site
      • Miami Lakes, Florida, Forenede Stater, 33016
        • Novo Nordisk Investigational Site
      • St. Petersburg, Florida, Forenede Stater, 33709
        • Novo Nordisk Investigational Site
    • Georgia
      • Roswell, Georgia, Forenede Stater, 30076
        • Novo Nordisk Investigational Site
    • Illinois
      • Avon, Illinois, Forenede Stater, 46123
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, Forenede Stater, 60611
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40502
        • Novo Nordisk Investigational Site
      • Madisonville, Kentucky, Forenede Stater, 42431
        • Novo Nordisk Investigational Site
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70002
        • Novo Nordisk Investigational Site
      • Slidell, Louisiana, Forenede Stater, 70461-4231
        • Novo Nordisk Investigational Site
    • Maryland
      • Rockville, Maryland, Forenede Stater, 20852
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, Forenede Stater, 01655
        • Novo Nordisk Investigational Site
    • Michigan
      • Southfield, Michigan, Forenede Stater, 48034-7661
        • Novo Nordisk Investigational Site
    • Missouri
      • Jefferson City, Missouri, Forenede Stater, 65109
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Novo Nordisk Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, Forenede Stater, 08648
        • Novo Nordisk Investigational Site
    • New York
      • Albany, New York, Forenede Stater, 12206
        • Novo Nordisk Investigational Site
      • Northport, New York, Forenede Stater, 11768
        • Novo Nordisk Investigational Site
      • Staten Island, New York, Forenede Stater, 10301
        • Novo Nordisk Investigational Site
    • North Carolina
      • Greenville, North Carolina, Forenede Stater, 27834
        • Novo Nordisk Investigational Site
    • Ohio
      • Franklin, Ohio, Forenede Stater, 45005
        • Novo Nordisk Investigational Site
      • Kettering, Ohio, Forenede Stater, 45429
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37411
        • Novo Nordisk Investigational Site
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Novo Nordisk Investigational Site
      • Nashville, Tennessee, Forenede Stater, 37212
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, Forenede Stater, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, Forenede Stater, 75246
        • Novo Nordisk Investigational Site
      • Dallas, Texas, Forenede Stater, 75218
        • Novo Nordisk Investigational Site
      • Kingsville, Texas, Forenede Stater, 78363-6322
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, Forenede Stater, 78207
        • Novo Nordisk Investigational Site
      • Schertz, Texas, Forenede Stater, 78154
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, Forenede Stater, 77478
        • Novo Nordisk Investigational Site
    • Washington
      • Tacoma, Washington, Forenede Stater, 98405
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53209
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • Manati, Puerto Rico, 00674
        • Novo Nordisk 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:

  • Type 2 diabetes
  • Current treatment with once daily insulin glargine in vials with a daily dose equal to or above 65 U and equal to or below 100 U
  • Current treatment with a stable dose of metformin plus/minus one additional oral antidiabetic drug (OAD) for at least 12 weeks
  • Glycosylated haemoglobin (HbA1c) equal to or above 7.5%

Exclusion Criteria:

  • Current treatment with insulin other than insulin glargine in vials
  • Treatment with thiazolidinediones or glucagon-like peptide-1 (GLP-1) receptor agonists within 12 weeks
  • Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty
  • Suffer from cancer (except basal cell skin cancer and squamous-cell cancer)

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: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: IDeg efterfulgt af IGlar
Medicin: insulin degludec
Cross-over trial, part 1: Individually adjusted IDeg administered subcutaneously (s.c., under the skin) once daily for 16 weeks in each treatment period.
Medicin: insulin glargine
Cross-over trial, part 2: Individually adjusted IGlar administered subcutaneously (s.c., under the skin) once daily for the 16 week run-in period followed by 16 weeks in each treatment period.
Eksperimentel: IGlar efterfulgt af IDeg
Medicin: insulin degludec
Cross-over trial, part 1: Individually adjusted IDeg administered subcutaneously (s.c., under the skin) once daily for 16 weeks in each treatment period.
Medicin: insulin glargine
Cross-over trial, part 2: Individually adjusted IGlar administered subcutaneously (s.c., under the skin) once daily for the 16 week run-in period followed by 16 weeks in each treatment period.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period
Tidsramme: Week 0, week 16 of each treatment period.
Values for change in HbA1c after each 16 weeks of treatment periods A and B.
Week 0, week 16 of each treatment period.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period
Tidsramme: Week 0, week 16 of each treatment period.
Changes in subjects quality of life and insulin device satisfaction were evaluated using the following PROs: the Short-Form 36 Health Survey version 2 (SF-36) and the Treatment Related Impact Measure-Diabetes Device (TRIM-DD). PRO total scores were measured from baseline to the end of each 16-week treatment period. Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.
Week 0, week 16 of each treatment period.
Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B
Tidsramme: Week 16, week 20
SF-36 and TRIM-DD total scores were measured at the end of treatment A (week 16) and 4 weeks into treatment B (week 20). Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.
Week 16, week 20
Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period
Tidsramme: Week 0, week 16, week 32
Values of FPG in mmol/L from baseline to each 16 weeks of treatment periods.
Week 0, week 16, week 32
Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B
Tidsramme: Week 16, week 20
Values of FPG in mmol/L from the end of treatment period A until after 4 weeks of treatment in treatment period B.
Week 16, week 20
Number of Adverse Events (AEs)
Tidsramme: From baseline to the end of each 16 week treatment period.
Number of treatment emergent adverse events (TEAEs) from week 0 to week 16 of the randomised treatment periods. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. TEAEs were attributed to the treatment given in the period in which the event occurred.
From baseline to the end of each 16 week treatment period.

Samarbejdspartnere og efterforskere

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

Sponsor

Novo Nordisk A/S

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

Hjælpsomme links

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. april 2012

Primær færdiggørelse (Faktiske)

1. januar 2014

Studieafslutning (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først indsendt

2. april 2012

Først indsendt, der opfyldte QC-kriterier

2. april 2012

Først opslået (Skøn)

4. april 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NN1250-3943
  • U1111-1123-4774 (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 2

Kliniske forsøg med insulin degludec

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Peru

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner