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Liraglutide as add-on to Insulin in Type 1 Diabetes (T1DMLIRA)

31. marts 2015 opdateret af: Christan SS Frandsen, MD, Hvidovre University Hospital

Treatment With Liraglutide as add-on to Insulin in Type 1 Diabetic Patients. Effects on Glycemic Control and Counterregulation and Cognitive Performance During Hypoglycaemia

The purpose of this study is to:

Part 1:

To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia.

Part 2:

To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects counterregulatory hormones and cognitive performance during hypoglycemia.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Danmark
    • Copenhagen
      • Hvidovre, Copenhagen, Danmark, 2650
        • Dept. of Endocrinology, Hvidovre University Hospital

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 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age: 18-70 years
  • BMI: 18-28
  • HbA1c ≥ 8 %
  • No residual β-cell function (glucagon test with c-peptide < 60 pM)
  • Caucasian
  • Diagnosed with type 1 diabetes at 5 to 40 years of age (both inclusive).
  • Remission phase must be completed
  • Female participants must use adequate contraception
  • Informed consent

Exclusion Criteria:

  • Overt diabetes complications; creatinin > 130 µM, proliferative retinopathy, macroalbuminuria.
  • Autonomic neuropathy (RR-variation </=10 beats/min) and/or Orthostatic hypotension (OH).
  • Anemia, Hb concentration; female <7.0 mmol/l, male<8.0 mmol/l
  • Pregnancy or lactation
  • Epilepsy
  • Use of antiepileptic medication
  • Use of beta blockers
  • Previously apoplexy cerebri.
  • Any use of benzodiazepine within the last month
  • Any use of neuroleptic drugs within the last six months
  • Self-perceived hearing loss
  • Alcohol or drug abuse
  • Allergy to the medication or placebo.
  • Treatment with any medication affecting glucose metabolism.
  • Any disorder which in the investigators opinion could interfere with the safety and results of the trial

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo + Insulin + Study 2
Study 2: Cognitive performance test
Medicin: Liraglutide
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.
Medicin: Liraglutide
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.
Eksperimentel: Liraglutide + Insulin + Study 2
Study 2: Cognitive performance test
Medicin: Placebo
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.
Medicin: Placebo
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.
Eksperimentel: Liraglutide + Insulin + Study 1
Study 1: Gastric emptying test
Medicin: Liraglutide
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.
Medicin: Liraglutide
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.
Placebo komparator: Placebo + Insulin + Study 1
Study 1: Gastric emptying test
Medicin: Placebo
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.
Medicin: Placebo
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline in HbA1c (glycosylated haemoglobin)
Tidsramme: Week 0, week 12
Week 0, week 12
Changes from baseline in EEG and cognitive performances
Tidsramme: week 0, week 12
week 0, week 12
Change from baseline in gastric emptying rate
Tidsramme: week 0, week 12
week 0, week 12

Sekundære resultatmål

Resultatmål
Tidsramme
Change from baseline in glycemic control (CGM)
Tidsramme: week 0, week 12
week 0, week 12
Change from baseline in total daily insulin dose
Tidsramme: week 0, week 12
week 0, week 12
Changes from baseline in the counterregulatory hormone responses during hypoglycemia
Tidsramme: week 0, week 12
week 0, week 12
Change from baseline in body weight
Tidsramme: week 0, week 12
week 0, week 12
Change from baseline in auditory evoked potentials (AEP) during hypoglycemia
Tidsramme: week 0, week 12
week 0, week 12
Change from baseline in corrected QTc-interval (QTc) during hypoglycemia
Tidsramme: week 0, week 12
week 0, week 12
Change from baseline in hypoglycemic symptom score
Tidsramme: week 0, week 12
week 0, week 12

Andre resultatmål

Resultatmål
Tidsramme
Frequency of Hypoglycemic episodes
Tidsramme: Week 0, week 12
Week 0, week 12

Samarbejdspartnere og efterforskere

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

Sponsor

Hvidovre University Hospital

Samarbejdspartnere

Novo Nordisk A/S
Hillerod Hospital, Denmark
Danish PhD schools of Molecular Metabolism and Endocrinology
NNF Center for Basal Metabolic Research, Denmark

Efterforskere

  • Ledende efterforsker: Christian SS Frandsen, MD, Hvidovre University Hospital

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

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. marts 2013

Primær færdiggørelse (Faktiske)

1. oktober 2014

Studieafslutning (Faktiske)

1. oktober 2014

Datoer for studieregistrering

Først indsendt

18. marts 2014

Først indsendt, der opfyldte QC-kriterier

18. marts 2014

Først opslået (Skøn)

20. marts 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2012-002526-67 (EudraCT nummer)

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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