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Effect of Two Different Fasting Blood Glucose Targets on Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily (TITRATE™)

30. januar 2017 opdateret af: Novo Nordisk A/S

Effect of Two Different Fasting Blood Glucose Titration Targets in Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily in Combination With 1-3 Oral Agents

This trial is conducted in the United States of America. The aim of this trial is to explore how different fasting blood glucose targets affect glucose control in patients with type 2 diabetes, when patients are empowered to do dose adjustments themselves.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

244

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Arizona
      • Goodyear, Arizona, Forenede Stater, 85395
        • Novo Nordisk Investigational Site
      • Scottsdale, Arizona, Forenede Stater, 85251-5638
        • Novo Nordisk Investigational Site
    • Arkansas
      • Searcy, Arkansas, Forenede Stater, 72143
        • Novo Nordisk Investigational Site
    • California
      • Artesia, California, Forenede Stater, 90701
        • Novo Nordisk Investigational Site
      • Escondido, California, Forenede Stater, 92025
        • Novo Nordisk Investigational Site
      • Fullerton, California, Forenede Stater, 92835-3404
        • Novo Nordisk Investigational Site
      • Los Angeles, California, Forenede Stater, 90057
        • Novo Nordisk Investigational Site
      • Los Angeles, California, Forenede Stater, 90036
        • Novo Nordisk Investigational Site
      • Orange, California, Forenede Stater, 92869
        • Novo Nordisk Investigational Site
      • Spring Valley, California, Forenede Stater, 91978
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, Forenede Stater, 94598
        • Novo Nordisk Investigational Site
    • Colorado
      • Parker, Colorado, Forenede Stater, 80138-8789
        • Novo Nordisk Investigational Site
    • Connecticut
      • Norwalk, Connecticut, Forenede Stater, 06851
        • Novo Nordisk Investigational Site
      • Prospect, Connecticut, Forenede Stater, 06712
        • Novo Nordisk Investigational Site
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33433
        • Novo Nordisk Investigational Site
      • Clearwater, Florida, Forenede Stater, 33755-2138
        • 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, 32205
        • Novo Nordisk Investigational Site
      • Lake Mary, Florida, Forenede Stater, 32746
        • Novo Nordisk Investigational Site
      • Plantation, Florida, Forenede Stater, 33324
        • Novo Nordisk Investigational Site
    • Georgia
      • Athens, Georgia, Forenede Stater, 30606
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, Forenede Stater, 30076
        • Novo Nordisk Investigational Site
      • Savannah, Georgia, Forenede Stater, 31406
        • Novo Nordisk Investigational Site
    • Idaho
      • Idaho Falls, Idaho, Forenede Stater, 83404-7596
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60607
        • Novo Nordisk Investigational Site
    • Indiana
      • Terre Haute, Indiana, Forenede Stater, 47802
        • Novo Nordisk Investigational Site
    • Kansas
      • Topeka, Kansas, Forenede Stater, 66606
        • Novo Nordisk Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Novo Nordisk Investigational Site
    • Maryland
      • Pikesville, Maryland, Forenede Stater, 21208-3737
        • Novo Nordisk Investigational Site
    • Minnesota
      • St. Paul, Minnesota, Forenede Stater, 55108
        • Novo Nordisk Investigational Site
    • Missouri
      • Chesterfield, Missouri, Forenede Stater, 63017-3632
        • Novo Nordisk Investigational Site
      • St. Louis, Missouri, Forenede Stater, 63141
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68114
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89101
        • Novo Nordisk Investigational Site
    • New Jersey
      • Berlin, New Jersey, Forenede Stater, 08009
        • Novo Nordisk Investigational Site
      • Camden, New Jersey, Forenede Stater, 08104
        • Novo Nordisk Investigational Site
      • Lawrenceville, New Jersey, Forenede Stater, 08648
        • Novo Nordisk Investigational Site
    • New York
      • New York, New York, Forenede Stater, 10023
        • Novo Nordisk Investigational Site
      • Staten Island, New York, Forenede Stater, 10301
        • Novo Nordisk Investigational Site
      • West Seneca, New York, Forenede Stater, 14224
        • Novo Nordisk Investigational Site
    • North Carolina
      • Shelby, North Carolina, Forenede Stater, 28152
        • Novo Nordisk Investigational Site
      • Statesville, North Carolina, Forenede Stater, 28625
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45245
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, Forenede Stater, 45439
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, Forenede Stater, 45406
        • Novo Nordisk Investigational Site
      • Mentor, Ohio, Forenede Stater, 44060
        • 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
      • Norristown, Pennsylvania, Forenede Stater, 19401
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Novo Nordisk Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Novo Nordisk Investigational Site
      • Taylors, South Carolina, Forenede Stater, 29687
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37404
        • Novo Nordisk Investigational Site
      • Chattanooga, Tennessee, Forenede Stater, 37411
        • Novo Nordisk Investigational Site
    • Texas
      • Arlington, Texas, Forenede Stater, 76014
        • Novo Nordisk Investigational Site
      • Dallas, Texas, Forenede Stater, 75390-9302
        • Novo Nordisk Investigational Site
      • Dallas, Texas, Forenede Stater, 75231
        • Novo Nordisk Investigational Site
      • Houston, Texas, Forenede Stater, 77024
        • Novo Nordisk Investigational Site
      • Houston, Texas, Forenede Stater, 77025
        • Novo Nordisk Investigational Site
      • Midland, Texas, Forenede Stater, 79707
        • Novo Nordisk Investigational Site
      • Odessa, Texas, Forenede Stater, 79761
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, Forenede Stater, 78209
        • Novo Nordisk Investigational Site
    • Washington
      • Spokane, Washington, Forenede Stater, 99218
        • Novo Nordisk Investigational Site
      • Spokane, Washington, Forenede Stater, 99204-2629
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53209
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Novo Nordisk Investigational Site
      • San Juan, Puerto Rico, 00921
        • Novo Nordisk Investigational Site
      • Trujillo Alto, Puerto Rico, 00976
        • 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
  • 1-3 oral treatments
  • Insulin naive
  • BMI (Body Mass Index) less than or equal to 45

Exclusion Criteria:

  • Pregnancy
  • Retinopathy
  • Cardiac disease
  • Uncontrolled hypertension
  • Recurrent hypoglycaemia

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: FPG 70-90 mg/dL
Aggressive FPG (fasting plasma glucose) titration target range group
Medicin: insulin detemir
Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL
Medicin: insulin detemir
Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 80-110 mg/dL
Eksperimentel: FPG 80-110 mg/dL
Conventional FPG (fasting plasma glucose) titration target range group
Medicin: insulin detemir
Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL
Medicin: insulin detemir
Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 80-110 mg/dL

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%
Tidsramme: week 20
Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment
week 20

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%
Tidsramme: week 20
Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment
week 20
Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline
Tidsramme: week -2, week 20
Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20
week -2, week 20
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
Tidsramme: weeks 0-20

Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) occurring during the treatment period from week 0 to week 20. Classification was as follows:

  • If subject was unable to treat himself: Major incidence.
  • If subject could treat himself and plasma glucose was less than 3.1 mmol/l: Minor incidence.
  • If subject could treat himself and plasma glucose was equal to or greater than 3.1 mmol/l, or there was no plasma glucose measurement: Symptoms only.
weeks 0-20

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. februar 2008

Primær færdiggørelse (Faktiske)

1. oktober 2008

Studieafslutning (Faktiske)

1. oktober 2008

Datoer for studieregistrering

Først indsendt

6. marts 2008

Først indsendt, der opfyldte QC-kriterier

6. marts 2008

Først opslået (Skøn)

13. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NN304-3502

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 .

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