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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

721

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

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: - 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

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: insulin degludec
Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.
Medicin: 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.
Medicin: insulin degludec
Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.
Medicin: insulin glargine
Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
Tidsramme
Andel af forsøgspersoner med en eller flere alvorlige hypoglykæmiske episoder i løbet af vedligeholdelsesperioden
Tidsramme: Efter 16 ugers behandling, i hver behandlingsperiode (uge 16-32 og uge 48-64)
Procentdel af forsøgspersoner, der oplevede en eller flere alvorlige hypoglykæmiske episoder i vedligeholdelsesperioden. Alvorlig hypoglykæmi (i henhold til definitionen af ​​American Diabetes Association 2013): En hypoglykæmisk episode, der kræver assistance fra en anden person til aktivt at administrere kulhydrat, glukagon eller tage andre korrigerende handlinger. Plasmaglukoseværdier er muligvis ikke tilgængelige under en hændelse, men neurologisk genopretning efter normalisering af plasmaglucose anses for tilstrækkeligt bevis for, at hændelsen blev induceret af en lav plasmaglukosekoncentration.
Efter 16 ugers behandling, i hver behandlingsperiode (uge 16-32 og uge 48-64)
Hyppighed af behandlingsudviklede bivirkninger
Tidsramme: I løbet af 32 ugers behandling for hver behandlingsperiode
Behandlingsudspringende bivirkning blev defineret som en hændelse med startdato på eller efter den første dag af eksponering for randomiseret behandling og senest den sidste dag af randomiseret behandling.
I løbet af 32 ugers 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

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 (Faktiske)

6. januar 2014

Primær færdiggørelse (Faktiske)

4. december 2015

Studieafslutning (Faktiske)

4. december 2015

Datoer for studieregistrering

Først indsendt

7. januar 2014

Først indsendt, der opfyldte QC-kriterier

7. januar 2014

Først opslået (Skøn)

8. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner