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Anti-diabetic Effects of Liraglutide in Adolescents and Young Subjects With Type 1 Diabetes

8. februar 2017 opdateret af: Paresh Dandona, University at Buffalo
This is the first prospective randomized double-blind placebo-controlled study to investigate the effect of a GLP-1 analog, specifically liraglutide, on blood glucose levels and variability in subjects with type 1 diabetes treated with insulin. Liraglutide is the preferred GLP-1 analog for this study because the pharmacokinetics and pharmacodynamics of the drug are consistent with a sustained duration of action. The current gold standard for management of type 1 diabetes is based on insulin replacement with novel analogs with specified pharmacodynamic profiles or with unique insulin delivery systems (insulin pump therapy). No other adjuvant therapy has demonstrated sustained benefit in this population. This study will also investigate the effect of liraglutide on suppression of glucagon secretion during meal challenges. This is of particular importance since, in the absence of insulin secretion from the β-cell, there is no paracrine inhibition of glucagon secretion by the α-cell. Dysregulation of glucagon secretion may impact the glycemic control and overall pathogenesis in those with type 1 diabetes. The use of CGM technology in this study will allow us to determine the rapidity, consistency, and sustainability of any response to liraglutide.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

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
    • New York
      • Williamsville, New York, Forenede Stater, 14221
        • Diabetes-Endocrinology Center of WNY

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

15 år til 30 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • INCLUSION CRITERIA:

    1. Females and males with Type 1 diabetes as ascertained by islet autoantibodies (GAD-65 and/or islet cell antibodies)
    2. Age 15-30 years - This age group is being chosen as most will have completed puberty with the accompanying physiologic phase of increased insulin resistance. In addition, this age group shows increased self-management capabilities. Extending the age up to 30 years will allow us to include young adults, since type 1 diabetes is frequently diagnosed in the late teen and early adult years. This study is not powered to detect differences in liraglutide efficacy in different age group but it may provide insight into the effectiveness in the teenage population, in whom optimal glycemic control is often a challenge.
    3. Type 1 diabetes duration greater than 1 year to ensure that a majority of subjects are beyond the partial remission period.
    4. Fasting C-peptide level ≤ 0.3 ng/ml.
    5. HbA1c level equal or less than 9%
    6. Insulin delivery by CSII - the choice is made to facilitate adherence to study drug and also to enable us have a homogeneous group to analyze without having to analyze the data for the covariants of CSII vs. multiple daily injection therapy.
    7. Subjects willing to wear a CGM sensor and perform home blood glucose monitoring four times daily and with symptoms of hypoglycemia.
    8. Subjects well-versed in carbohydrate counting.
    9. BMI < 95th% for age and gender.

Exclusion Criteria:

  • EXCLUSION CRITERIA:

    1. Previous exposure to liraglutide
    2. History of abdominal surgery
    3. History of gastroparesis or gastrointestinal reflux disease;
    4. History of acute or chronic pancreatitis
    5. Cirrhosis or hepatic disease defined as transaminases levels > 3 times normal
    6. Impaired renal function defined as serum creatinine >1.5.
    7. HIV or Hepatitis C positive status
    8. Pregnant/breastfeeding females
    9. Individuals with steroid-induced or cystic fibrosis related diabetes
    10. Diabetic Ketoacidosis within 6 months of the study
    11. History of severe hypoglycemia (seizure, loss of consciousness) within 6 months of the study
    12. History of medullary thyroid cancer or MEN2 syndrome
    13. Any other life-threatening cardiac or non-cardiac disease
    14. Participation in a concurrent clinical trial or participation in a trial within 30 days preceding the study period.
    15. Unable to give informed consent/assent.

    16. Adolescents and adults who are considered underweight based on body mass index (BMI):

      1. For adolescents: BMI less than the 5th percentile
      2. For adults: BMI below 18.5

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Liraglutide 0.6mg
Daily Injection
Medicin: Liraglutid
Placebo komparator: Placebo
Daglig injektion
Medicin: Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean weekly blood glucose concentrations.
Tidsramme: 3 Months
The primary endpoint of the study is to detect a difference between Liraglutide and placebo groups in the change from baseline in mean weekly blood glucose concentrations after 12 weeks of treatment.
3 Months

Sekundære resultatmål

Resultatmål
Tidsramme
HbA1c
Tidsramme: 3 Months
3 Months

Samarbejdspartnere og efterforskere

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

Sponsor

University at Buffalo

Samarbejdspartnere

American Diabetes Association

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. november 2012

Primær færdiggørelse (Forventet)

1. november 2017

Studieafslutning (Forventet)

1. maj 2018

Datoer for studieregistrering

Først indsendt

2. november 2012

Først indsendt, der opfyldte QC-kriterier

5. november 2012

Først opslået (Skøn)

6. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1964 Liraglutide ADA
  • 1-12-CT-20 (Andet bevillings-/finansieringsnummer: American Diabetes Association)

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 Type 1 diabetes

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Finland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner