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Basal-bolus Insulin Therapy Versus Standard Therapy for the Inpatient Management of Type 2 Diabetes: the IDA2 Study

8. august 2017 opdateret af: Merete Bechmann Christensen

Basal-bolus Insulin Therapy With Insulin Degludec and Insulin Aspart Versus Standard Therapy for the Inpatient Management of Type 2 Diabetes: the IDA2 Study

Hyperglycemia during admission is associated with increased rate of complications and longer hospital stays, thus insulin treatment is recommended for all diabetes patients with hyperglycemia. Inpatient studies of non-critically ill patients show better glycemic control with the use of basal-bolus insulin therapy compared to sliding scale insulin therapy, but increased rates of hypoglycemia. The investigators hypothesize that basal-bolus insulin therapy with a new ultra-long-action basal insulin can treat hyperglycemia more efficiently than sliding scale insulin, with few episodes of hypoglycemia.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The aim of this study is to investigate and compare the efficacy and safety of basal-bolus insulin therapy using the insulin analogue, insulin degludec once daily and insulin aspart before meals versus standard therapy with sliding scale insulin in non-critical ill hospitalized patients with type 2 diabetes.

The design of the trial is an open, randomized controlled trial with two parallel arms (treatment arm and control arm). Randomization is 1:1.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

100

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

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 til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • History of type 2 diabetes for at least 6 months
  • Age 18 - 90 years
  • Pre-meal plasma glucose in the range 10 - 22,2 mmol/L prior to inclusion
  • Expected hospital stay longer than 4 days

Exclusion Criteria:

  • Hyperglycemia without known history of type 2 diabetes
  • Type 1 diabetes mellitus
  • Severely impaired renal function (eGFR ≤ 30 mL/min/1,73 m2)
  • Severe hepatic disease
  • Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months
  • Pregnant or lactating women or fertile female patients not using chemical, hormonal or mechanical contraceptives or not in menopause (i.e. must not have had regular menstrual bleeding for at least one year)
  • Planned treatment during hospital stay with intravenous glucose/ insulin for ≥ 12 hours
  • Treatment at admission or planned treatment during hospital stay with parenteral nutrition or enteral nutrition (i.e. gastroenteric tube feeding)
  • Treatment at admission or planned treatment during hospital stay with high dose glucocorticoids (>40 mg)
  • History or presence of malignancy (except basal skin cancer) unless a disease-free period exceeding five years
  • Presence of alcohol or drug abuse
  • Inability to understand the written information or incapability to provide informed consent

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
Aktiv komparator: Intervention
Basal-bolus insulin regime with Insulin Degludec and insulin aspart
Medicin: Insulin Degludec 100 UNT/ML [Tresiba]
Basal-bolus insulin regime
Ingen indgriben: Standard
Standard treatment according to hospital guidelines with sliding scale insulin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in mean daily plasma glucose between the two groups
Tidsramme: Duration of hospital stay, an expected average of 8 days
Difference in mean daily plasma glucose between the two groups, calculated by using the four daily pre-meal and bedside PG values per patient.
Duration of hospital stay, an expected average of 8 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean number and rates of hypoglycemic events (PG ≤ 3.9 mmol/L)
Tidsramme: Duration of hospital stay, an expected average of 8 days
Based on bedside PG measures and on CGM data
Duration of hospital stay, an expected average of 8 days
Time spent in glycemic range
Tidsramme: Duration of hospital stay, an expected average of 8 days
Based on bedside PG measures and on CGM data
Duration of hospital stay, an expected average of 8 days
Time spent in hyperglycemic range
Tidsramme: Duration of hospital stay, an expected average of 8 days
Based on bedside PG measures and on CGM data
Duration of hospital stay, an expected average of 8 days
Length of hospital stay
Tidsramme: Duration of hospital stay, an expected average of 8 days
Mean duration of hospital stay
Duration of hospital stay, an expected average of 8 days
Difference in insulin dose between groups
Tidsramme: Duration of hospital stay, an expected average of 8 days
Calculated as mean insulin dose during admission
Duration of hospital stay, an expected average of 8 days
Number of hospital acquired infections during admission
Tidsramme: Duration of hospital stay, an expected average of 8 days
Data from hospital record
Duration of hospital stay, an expected average of 8 days
Number of post-discharge infections or re-admissions 1 month after discharge
Tidsramme: 1 month
Data collected on follow-up 1 month after discharge
1 month

Samarbejdspartnere og efterforskere

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

Sponsor

Merete Bechmann Christensen

Samarbejdspartnere

Novo Nordisk A/S

Efterforskere

  • Ledende efterforsker: Kirsten B Norgaard, DMSC, Hvidovre University Hospital

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. april 2017

Primær færdiggørelse (Forventet)

1. april 2018

Studieafslutning (Forventet)

1. april 2018

Datoer for studieregistrering

Først indsendt

7. juni 2017

Først indsendt, der opfyldte QC-kriterier

8. august 2017

Først opslået (Faktiske)

9. august 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. august 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. august 2017

Sidst verificeret

1. august 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • U1111-1177-2744

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Type 2 diabetes mellitus

Kliniske forsøg med Insulin Degludec 100 UNT/ML [Tresiba]

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