Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes (SWITCH 2)

30. april 2019 oppdatert av: Novo Nordisk A/S

A Randomised, Double Blind, Cross-over Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes (SWITCH 2)

This trial is conducted in the United States of America (USA). The aim of the trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar) with or without OADs (oral anti-diabetic drugs) excluding SUs (sulfonylureas)/glinides in subjects with type 2 diabetes.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

721

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35216
        • Novo Nordisk Investigational Site
      • Birmingham, Alabama, Forente stater, 35215-7502
        • Novo Nordisk Investigational Site
      • Haleyville, Alabama, Forente stater, 35565-1719
        • Novo Nordisk Investigational Site
      • Montgomery, Alabama, Forente stater, 36106
        • Novo Nordisk Investigational Site
      • Tuscumbia, Alabama, Forente stater, 35674
        • Novo Nordisk Investigational Site
    • Arizona
      • Chandler, Arizona, Forente stater, 85224
        • Novo Nordisk Investigational Site
      • Phoenix, Arizona, Forente stater, 85050
        • Novo Nordisk Investigational Site
      • Tucson, Arizona, Forente stater, 85704
        • Novo Nordisk Investigational Site
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • Novo Nordisk Investigational Site
    • California
      • Costa Mesa, California, Forente stater, 92626
        • Novo Nordisk Investigational Site
      • Downey, California, Forente stater, 90242
        • Novo Nordisk Investigational Site
      • El Cajon, California, Forente stater, 92020
        • Novo Nordisk Investigational Site
      • Fresno, California, Forente stater, 93720
        • Novo Nordisk Investigational Site
      • Fresno, California, Forente stater, 93702
        • Novo Nordisk Investigational Site
      • Hawaiian Gardens, California, Forente stater, 90716
        • Novo Nordisk Investigational Site
      • Huntington Park, California, Forente stater, 90255
        • Novo Nordisk Investigational Site
      • Lincoln, California, Forente stater, 95648
        • Novo Nordisk Investigational Site
      • Long Beach, California, Forente stater, 90807
        • Novo Nordisk Investigational Site
      • Montclair, California, Forente stater, 91763
        • Novo Nordisk Investigational Site
      • North Hollywood, California, Forente stater, 91606
        • Novo Nordisk Investigational Site
      • Northridge, California, Forente stater, 91325
        • Novo Nordisk Investigational Site
      • Pomona, California, Forente stater, 91766-2007
        • Novo Nordisk Investigational Site
      • Poway, California, Forente stater, 92064
        • Novo Nordisk Investigational Site
      • Rancho Cucamonga, California, Forente stater, 91730-3063
        • Novo Nordisk Investigational Site
      • Rialto, California, Forente stater, 92376
        • Novo Nordisk Investigational Site
      • Roseville, California, Forente stater, 95661
        • Novo Nordisk Investigational Site
      • San Diego, California, Forente stater, 92111
        • Novo Nordisk Investigational Site
      • Santa Monica, California, Forente stater, 90404
        • Novo Nordisk Investigational Site
      • Tarzana, California, Forente stater, 91356-3551
        • Novo Nordisk Investigational Site
      • Torrance, California, Forente stater, 90502
        • Novo Nordisk Investigational Site
      • Tustin, California, Forente stater, 92780
        • Novo Nordisk Investigational Site
    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80910
        • Novo Nordisk Investigational Site
      • Golden, Colorado, Forente stater, 80401
        • Novo Nordisk Investigational Site
    • Delaware
      • Newark, Delaware, Forente stater, 19713
        • Novo Nordisk Investigational Site
    • Florida
      • Bradenton, Florida, Forente stater, 34201
        • Novo Nordisk Investigational Site
      • Chiefland, Florida, Forente stater, 32626
        • Novo Nordisk Investigational Site
      • Clearwater, Florida, Forente stater, 33765
        • Novo Nordisk Investigational Site
      • Clearwater, Florida, Forente stater, 33756
        • Novo Nordisk Investigational Site
      • Cooper City, Florida, Forente stater, 33024
        • Novo Nordisk Investigational Site
      • Doral, Florida, Forente stater, 33166
        • Novo Nordisk Investigational Site
      • Hialeah, Florida, Forente stater, 33012
        • Novo Nordisk Investigational Site
      • Hialeah, Florida, Forente stater, 33013
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, Forente stater, 32216
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, Forente stater, 32204
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, Forente stater, 32256
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, Forente stater, 32277
        • Novo Nordisk Investigational Site
      • Miami, Florida, Forente stater, 33156
        • Novo Nordisk Investigational Site
      • Miami, Florida, Forente stater, 33174
        • Novo Nordisk Investigational Site
      • Miami, Florida, Forente stater, 33175
        • Novo Nordisk Investigational Site
      • Miami, Florida, Forente stater, 33130
        • Novo Nordisk Investigational Site
      • Miami, Florida, Forente stater, 33155
        • Novo Nordisk Investigational Site
      • Miami, Florida, Forente stater, 33165
        • Novo Nordisk Investigational Site
      • Miami, Florida, Forente stater, 33186
        • Novo Nordisk Investigational Site
      • Miami Springs, Florida, Forente stater, 33166
        • Novo Nordisk Investigational Site
      • Miramar, Florida, Forente stater, 33027
        • Novo Nordisk Investigational Site
      • New Port Richey, Florida, Forente stater, 34652
        • Novo Nordisk Investigational Site
      • Ocala, Florida, Forente stater, 34470
        • Novo Nordisk Investigational Site
      • Orlando, Florida, Forente stater, 32801
        • Novo Nordisk Investigational Site
      • Panama City, Florida, Forente stater, 32401
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, Forente stater, 33026
        • Novo Nordisk Investigational Site
      • Tampa, Florida, Forente stater, 33607
        • Novo Nordisk Investigational Site
      • Tampa, Florida, Forente stater, 33619
        • Novo Nordisk Investigational Site
    • Georgia
      • Perry, Georgia, Forente stater, 31069
        • Novo Nordisk Investigational Site
    • Illinois
      • Champaign, Illinois, Forente stater, 61821
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, Forente stater, 60611
        • Novo Nordisk Investigational Site
    • Indiana
      • Evansville, Indiana, Forente stater, 47714
        • Novo Nordisk Investigational Site
      • Muncie, Indiana, Forente stater, 47304
        • Novo Nordisk Investigational Site
    • Iowa
      • West Des Moines, Iowa, Forente stater, 50265
        • Novo Nordisk Investigational Site
    • Kansas
      • Lenexa, Kansas, Forente stater, 66219
        • Novo Nordisk Investigational Site
      • Newton, Kansas, Forente stater, 67114
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40503
        • Novo Nordisk Investigational Site
      • Lexington, Kentucky, Forente stater, 40502
        • Novo Nordisk Investigational Site
      • Louisville, Kentucky, Forente stater, 40213
        • Novo Nordisk Investigational Site
      • Paducah, Kentucky, Forente stater, 42003
        • Novo Nordisk Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70119
        • Novo Nordisk Investigational Site
      • Shreveport, Louisiana, Forente stater, 71105
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Brockton, Massachusetts, Forente stater, 02301
        • Novo Nordisk Investigational Site
    • Michigan
      • Kalamazoo, Michigan, Forente stater, 49009
        • Novo Nordisk Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, Forente stater, 38654-3573
        • Novo Nordisk Investigational Site
    • Missouri
      • Florissant, Missouri, Forente stater, 63031
        • Novo Nordisk Investigational Site
      • Jefferson City, Missouri, Forente stater, 65109
        • Novo Nordisk Investigational Site
      • Kansas City, Missouri, Forente stater, 64106
        • Novo Nordisk Investigational Site
    • Nevada
      • Henderson, Nevada, Forente stater, 89052-2649
        • Novo Nordisk Investigational Site
      • Las Vegas, Nevada, Forente stater, 89148
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Newington, New Hampshire, Forente stater, 03801
        • Novo Nordisk Investigational Site
    • New Jersey
      • Morganville, New Jersey, Forente stater, 07751
        • Novo Nordisk Investigational Site
      • Teaneck, New Jersey, Forente stater, 07666
        • Novo Nordisk Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87102
        • Novo Nordisk Investigational Site
    • New York
      • Albany, New York, Forente stater, 12208
        • Novo Nordisk Investigational Site
      • Jackson Heights, New York, Forente stater, 11372
        • Novo Nordisk Investigational Site
      • New Windsor, New York, Forente stater, 12553
        • Novo Nordisk Investigational Site
      • Northport, New York, Forente stater, 11768
        • Novo Nordisk Investigational Site
      • Smithtown, New York, Forente stater, 11787
        • Novo Nordisk Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28277
        • Novo Nordisk Investigational Site
      • Morganton, North Carolina, Forente stater, 28655
        • Novo Nordisk Investigational Site
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Novo Nordisk Investigational Site
    • Ohio
      • Delaware, Ohio, Forente stater, 43015
        • Novo Nordisk Investigational Site
      • Franklin, Ohio, Forente stater, 45005
        • Novo Nordisk Investigational Site
      • Toledo, Ohio, Forente stater, 43614
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73103
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, Forente stater, 16602
        • Novo Nordisk Investigational Site
      • Beaver, Pennsylvania, Forente stater, 15009
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, Forente stater, 19114
        • Novo Nordisk Investigational Site
      • Scottdale, Pennsylvania, Forente stater, 15683
        • Novo Nordisk Investigational Site
    • South Carolina
      • Anderson, South Carolina, Forente stater, 29621
        • Novo Nordisk Investigational Site
      • Gaffney, South Carolina, Forente stater, 29341
        • Novo Nordisk Investigational Site
      • Greer, South Carolina, Forente stater, 29651
        • Novo Nordisk Investigational Site
      • Pelzer, South Carolina, Forente stater, 29669
        • Novo Nordisk Investigational Site
      • Spartanburg, South Carolina, Forente stater, 29303
        • Novo Nordisk Investigational Site
    • South Dakota
      • Rapid City, South Dakota, Forente stater, 57701
        • Novo Nordisk Investigational Site
    • Tennessee
      • Bristol, Tennessee, Forente stater, 37620-7352
        • Novo Nordisk Investigational Site
      • Bristol, Tennessee, Forente stater, 37620
        • Novo Nordisk Investigational Site
      • Chattanooga, Tennessee, Forente stater, 37404
        • Novo Nordisk Investigational Site
      • Humboldt, Tennessee, Forente stater, 38343
        • Novo Nordisk Investigational Site
      • Jackson, Tennessee, Forente stater, 38305
        • Novo Nordisk Investigational Site
      • Johnson City, Tennessee, Forente stater, 37604
        • Novo Nordisk Investigational Site
      • Kingsport, Tennessee, Forente stater, 37660
        • Novo Nordisk Investigational Site
    • Texas
      • Arlington, Texas, Forente stater, 76012-4637
        • Novo Nordisk Investigational Site
      • Arlington, Texas, Forente stater, 76012
        • Novo Nordisk Investigational Site
      • Austin, Texas, Forente stater, 78758
        • Novo Nordisk Investigational Site
      • Carrollton, Texas, Forente stater, 75007
        • Novo Nordisk Investigational Site
      • Dallas, Texas, Forente stater, 75208
        • Novo Nordisk Investigational Site
      • El Paso, Texas, Forente stater, 79912
        • Novo Nordisk Investigational Site
      • Fort Worth, Texas, Forente stater, 76104
        • Novo Nordisk Investigational Site
      • Houston, Texas, Forente stater, 77040
        • Novo Nordisk Investigational Site
      • Houston, Texas, Forente stater, 77072
        • Novo Nordisk Investigational Site
      • Houston, Texas, Forente stater, 77070
        • Novo Nordisk Investigational Site
      • Houston, Texas, Forente stater, 77043
        • Novo Nordisk Investigational Site
      • Houston, Texas, Forente stater, 77060
        • Novo Nordisk Investigational Site
      • Houston, Texas, Forente stater, 77077
        • Novo Nordisk Investigational Site
      • Humble, Texas, Forente stater, 77338
        • Novo Nordisk Investigational Site
      • Hurst, Texas, Forente stater, 76054
        • Novo Nordisk Investigational Site
      • Marshall, Texas, Forente stater, 75670
        • Novo Nordisk Investigational Site
      • Mesquite, Texas, Forente stater, 75149
        • Novo Nordisk Investigational Site
      • North Richland Hills, Texas, Forente stater, 76180
        • Novo Nordisk Investigational Site
      • Plano, Texas, Forente stater, 75075
        • Novo Nordisk Investigational Site
      • Plano, Texas, Forente stater, 75093
        • Novo Nordisk Investigational Site
      • Richardson, Texas, Forente stater, 75080
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, Forente stater, 78229
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, Forente stater, 78215
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, Forente stater, 78224
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, Forente stater, 78240
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, Forente stater, 78258
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, Forente stater, 78228-3419
        • Novo Nordisk Investigational Site
      • Sealy, Texas, Forente stater, 77474
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, Forente stater, 77478
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, Forente stater, 77479
        • Novo Nordisk Investigational Site
      • Victoria, Texas, Forente stater, 77901
        • Novo Nordisk Investigational Site
      • Waco, Texas, Forente stater, 76710
        • Novo Nordisk Investigational Site
    • Utah
      • Draper, Utah, Forente stater, 84020
        • Novo Nordisk Investigational Site
      • Ogden, Utah, Forente stater, 84405
        • Novo Nordisk Investigational Site
      • Salt Lake City, Utah, Forente stater, 84107
        • Novo Nordisk Investigational Site
    • Virginia
      • Chesapeake, Virginia, Forente stater, 23321
        • Novo Nordisk Investigational Site
      • Norfolk, Virginia, Forente stater, 23510
        • Novo Nordisk Investigational Site
    • Washington
      • Olympia, Washington, Forente stater, 98502
        • Novo Nordisk Investigational Site
      • Renton, Washington, Forente stater, 98057
        • Novo Nordisk Investigational Site
      • Richland, Washington, Forente stater, 99352
        • Novo Nordisk Investigational Site
      • Spokane, Washington, Forente stater, 99202-1334
        • Novo Nordisk Investigational Site
    • West Virginia
      • Martinsburg, West Virginia, Forente stater, 25401
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Kenosha, Wisconsin, Forente stater, 53144
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • Carolina, Puerto Rico, 00983
        • Novo Nordisk Investigational Site
      • Manati, Puerto Rico, 00674
        • Novo Nordisk Investigational Site
      • Ponce, Puerto Rico, 00717
        • Novo Nordisk Investigational Site
      • San Juan, Puerto Rico, 00921
        • Novo Nordisk Investigational Site
      • San Juan, Puerto Rico, 00918
        • Novo Nordisk Investigational Site

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Subjects fulfilling at least one of the below criteria: a) Experienced at least one severe hypoglycaemic episode within last year (according to the ADA (American Diabetes Association) definition, April 2013), b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-Epi (Chronic Kidney Disease Epidemiology Collaboration) by central laboratory analysis, c) Hypoglycaemic symptom unawareness, d) Exposed to insulin for more than 5 years, e) Recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dL [below or equal to 3.9 mmol/L])) within the last 12 weeks prior to Visit 1 (screening) - Type 2 diabetes mellitus (diagnosed clinically) for at least 26 weeks prior to Visit 1 - Current treatment with any basal insulin (OD or BID) ± any combination of OADs (metformin, DPP-4 inhibitor, alpha-glucosidase inhibitor, thiazolidinediones, and SGLT2-inhibitor) for 26 weeks or longer prior to Visit 1 For subjects on BID the total daily dose should be below 75 units - HbA1c (glycosylated haemoglobin) below or equal to 9.5 % by central laboratory analysis - BMI (body mass index) below or equal to 45 kg/m^2 Exclusion Criteria: - Treatment with a bolus insulin separately or contained in an insulin mix product within the last 26 weeks prior to Visit 1 - Use of any other anti-diabetic agent(s) than those stated in the inclusion criteria within the last 26 weeks prior to Visit 1

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: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: IDeg OD ± OADs followed by IGlar OD ± OADs
The trial includes two 32-week treatment periods in a cross-over design. Total trial duration for the individual subjects will be up to 67 weeks.
Legemiddel: insulin degludec
Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.
Legemiddel: insulin glargine
Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.
Aktiv komparator: IGlar OD ± OADs followed by IDeg OD ± OADs
The trial includes two 32-week treatment periods in a cross-over design. Total trial duration for the individual subjects will be up to 67 weeks.
Legemiddel: insulin degludec
Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.
Legemiddel: insulin glargine
Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period
Tidsramme: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Andel forsøkspersoner med en eller flere alvorlige hypoglykemiske episoder i løpet av vedlikeholdsperioden
Tidsramme: Etter 16 ukers behandling, i hver behandlingsperiode (uke 16-32 og uke 48-64)
Prosentandel av personer som opplevde en eller flere alvorlige hypoglykemiske episoder i vedlikeholdsperioden. Alvorlig hypoglykemi (i henhold til definisjonen av American Diabetes Association 2013): En hypoglykemisk episode som krever assistanse fra en annen person til aktivt å administrere karbohydrater, glukagon eller ta andre korrigerende tiltak. Plasmaglukoseverdier er kanskje ikke tilgjengelige under en hendelse, men nevrologisk restitusjon etter normalisering av plasmaglukose anses som tilstrekkelig bevis på at hendelsen ble indusert av lav plasmaglukosekonsentrasjon.
Etter 16 ukers behandling, i hver behandlingsperiode (uke 16-32 og uke 48-64)
Forekomst av behandlingsopptredende uønskede hendelser
Tidsramme: I løpet av 32 ukers behandling for hver behandlingsperiode
Behandlingsoppstått bivirkning ble definert som en hendelse med startdato på eller etter den første dagen av eksponering for randomisert behandling og ikke senere enn siste dag av randomisert behandling.
I løpet av 32 ukers behandling for hver behandlingsperiode
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episode During the Maintenance Period
Tidsramme: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
Severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia and with time of onset between 00:01 and 05.59 a.m., both inclusive. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Tidsramme: Week 32, Week 64
Change from baseline in HbA1c (glycosylated haemoglobin) at week 32 (treatment period 1) and at week 64 (treatment period 2). Week 32 HbA1c value was considered as baseline for calculating change from baseline in HbA1c at week 64.
Week 32, Week 64
FPG (Fasting Plasma Glucose)
Tidsramme: week 32, week 64
Fasting plasma glucose values at week 32 and week 64.
week 32, week 64

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novo Nordisk A/S

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

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 (Faktiske)

6. januar 2014

Primær fullføring (Faktiske)

4. desember 2015

Studiet fullført (Faktiske)

4. desember 2015

Datoer for studieregistrering

Først innsendt

7. januar 2014

Først innsendt som oppfylte QC-kriteriene

7. januar 2014

Først lagt ut (Anslag)

8. januar 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. mai 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. april 2019

Sist bekreftet

1. april 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NN1250-3998
  • U1111-1143-7963 (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. .

Abonnere