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Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases (MAG1C)

9. juli 2019 opdateret af: Filip Krag Knop

Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases: A Randomised, Placebo-controlled Trial

Patients with type 1 diabetes (T1D) depend on insulin therapy as substitution for the lack of endocrine insulin production due to an autoimmune destruction of beta-cells in the pancreatic inslets. Insulin therapy is based on long lasting basal insulin for controlling fasting plasma glucose, and short lasting mealtime insulin for the postprandial plasma glucose. The long term efficacy of this treatment is measured in glycated haemoglobin A1c (HbA1c) of <7.0% as the treatment goal.

Intensive insulin therapy is associated with side effects such as hypoglycaemia, weight gain, and unwanted exaggerated excursions in PPG. This may ultimately affect treatment compliance.

The abovementioned problems associated with insulin treatment in T1D can also be seen in insulin-treated patients with type 2 diabetes (T2D). However, in T2D the combination of insulin with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) has proven effective in reducing the weight gain and insulin dose in insulin-treated patients with T2D without exacerbating the risk of hypoglycaemia.

Exenatid is a short lasting GLP-1RA approved for treatment in T2D, and the investigators intend to evaluate it in a randomized, controlled trial as add-on therapy to standard insulin therapy for patients with T1D.

The investigators hypothesise that the add-on of exenatide to insulin therapy in patients with T1D will reduce insulin requirements, glycaemic excursions and body weight and improve glycaemic control without increasing the risk of hypoglycaemia.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

108

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Danmark
    • Capital Region
      • Gentofte, Capital Region, Danmark, 2820
        • Steno Diabetes Center Copenhagen

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 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • T1D according to WHO criteria with duration of ≥1 year
  • Age ≥18 years
  • BMI >22.0 kg/m2
  • HbA1c >7.5% and <10.0% at visit 0 (screening)
  • Able to count carbohydrates

Exclusion Criteria:

  • Insulin pump treatment
  • Hypoglycaemia unawareness (inability to register low blood glucose)
  • Diabetic gastroparesis
  • Compromised kidney function (eGFR <60 ml/min/1.73m2, dialysis or kidney transplantation)
  • Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
  • History of acute and/or chronic pancreatitis
  • Subjects with personal or family history of medullary carcinoma or MEN syndrome
  • Inflammatory bowel disease
  • Cancer unless in complete remission for >5 years
  • Proliferative retinopathy
  • Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
  • Alcohol/drug abuse
  • Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
  • Pregnant or nursing women
  • Known or suspected hypersensitivity to trial product or related products
  • Receipt of an investigational drug within 30 days prior to visit 0
  • Simultaneous participation in any other clinical intervention 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
Eksperimentel: Intervention
Exenatide 10 mikrogram, thrice daily, subcutaneous injection prior to main meals, 6 months.
Medicin: Exenatid
Andre navne:
  • Byetta
Placebo komparator: Placebo
Placebo, thrice daily, subcutaneous injection prior to main meals, 6 months.
Medicin: Placebos

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in HbA1c
Tidsramme: 6 months
Change in HbA1c from baseline to end of study (time 6 months)
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
adverse events (including hypoglycaemic episodes)
Tidsramme: 6 months
6 months
changes in insulin dosage
Tidsramme: 6 months
6 months
changes in body weight
Tidsramme: 6 months
6 months
changes in BMI
Tidsramme: 6 months
6 months
changes in body composition
Tidsramme: 6 months
DXA scan measuring bonemineral density
6 months
changes in body composition
Tidsramme: 6 months
DXA scan measuring lean mass
6 months
changes in body composition
Tidsramme: 6 months
DXA scan measuring fat mass
6 months
changes in fasting plasma glucose
Tidsramme: 6 months
6 months
changes in post prandial plasma glucose
Tidsramme: 6 months
6 months
changes in fasting plasma levels of C-peptide
Tidsramme: 6 months
6 months
Quality of life self reported
Tidsramme: 6 months
Quality of Life Questionaire
6 months
Treatment satisfaction
Tidsramme: 6 months
Diabetes treatment satisfactory questionnaire status version
6 months
Treatment satisfaction
Tidsramme: 6 months
Diabetes treatment satisfactory questionnaire change version
6 months
dietary patterns
Tidsramme: 6 months
Food frequency questionaire three times during the intervention
6 months
HDL (High Density Lipoprotein)
Tidsramme: 6 months
6 months
LDL (Low Density Lipoprotein)
Tidsramme: 6 months
6 months
VLDL (Very Low Density Lipoprotein)
Tidsramme: 6 months
6 months
total kolesterol
Tidsramme: 6 måneder
6 måneder
triglycerides
Tidsramme: 6 months
6 months
proBNP (Pro-Brain Natriuretic Peptide)
Tidsramme: 6 months
6 months
hsCRP (High-Sensitivity C-Reactive Protein)
Tidsramme: 6 months
6 months

Samarbejdspartnere og efterforskere

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

Sponsor

Filip Krag Knop

Samarbejdspartnere

Steno Diabetes Center Copenhagen

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. december 2016

Primær færdiggørelse (Faktiske)

1. juni 2019

Studieafslutning (Faktiske)

1. juni 2019

Datoer for studieregistrering

Først indsendt

2. januar 2017

Først indsendt, der opfyldte QC-kriterier

9. januar 2017

Først opslået (Skøn)

11. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Eudract-nr.: 2016-001365-92

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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