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Human Insulin Analogs: Evaluation of Inflammatory mRNA Expression of Macrophages and Endothelial Function of Short-acting Insulin - HERMES Pilot Study (HERMES)

2. marts 2012 opdateret af: Marcus Borchert, ikfe-CRO GmbH
The planned HERMES study is to investigate and compare the effects of Insulin Glulisine, Insulin Aspart and regular human insulin on postprandial nitrotyrosine concentrations and several clinical and laboratory markers of postprandial endothelial cell function, sub-clinical inflammation and cardiovascular risk in patients with type 2 DM. The primary parameter in this study are the postprandial changes in the nitrotyrosine concentrations, a biomarker for oxidative stress. As vascular data on Insulin Glulisine vs. Insulin Aspart are missing, it is not possible to calculate sample size and statistical power. Therefore the goal of the HERMES-Pilot-Study is to generate preliminary data for statistical considerations and estimations on the probability of success of HERMES.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

12

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Tyskland
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Tyskland, 55116
        • ife GmbH, Clinic

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

30 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Stable BOT (basal oral therapy) with Insulin Glargine + ≥ 2 OHA (oral hypoglycemic agents except for TZD) for a minimum of three months before entering the study
  • HbA1c ≤ 8.5%
  • Age between 30 and 75 years inclusively
  • Body mass index ≤ 40 kg/m2
  • Patient consents that his/her family physician will be informed of trial participation

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Unspecific infection or inflammation (hsCRP >10mg/L in POC test)
  • Use of thiazolidinediones within the last 3 months prior to study start
  • Retinopathy, hepatic or renal dysfunction or clinically relevant other major diseases
  • History of drug or alcohol abuse within the last five years prior to screening
  • History of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures
  • History of severe or multiple allergies
  • Treatment with any other investigational drug within 3 months prior to screening
  • Progressive fatal disease
  • hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.3 mg/dl in women and > 1.6 mg/dl in men), neurological, psychiatric and/or hematological disease as judged by the investigator
  • Pregnant or lactating women
  • Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner
  • Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study

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: Insulin Glulisine: bolus injections before each main meal
Patients are already on an Insulin Glargine therapy when they start and will them after randomization receive additionally Insulin Glulisine bolus injections before each of the main meals.
Medicin: Insulin glulisine
Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.
Andre navne:
  • Apidra
Aktiv komparator: Insulin Aspart: bolus injections before each main meal
Patients are already on an Insulin Glargine ± metformin therapy when they start the start and will them after randomization receive additionally Insulin Aspart bolus injections before each of the main meals.
Medicin: Insulin aspart
Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.
Andre navne:
  • NovoRapid
Aktiv komparator: Regular human insulin:bolus injections before each main meal
Patients are already on an Insulin Glargine ± metformin therapy when they start the start and will them after randomization receive additionally regular human insulin bolus injections before each of the main meals.
Medicin: Regular human insulin
Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.
Andre navne:
  • InsumanRapid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Nitrotyrosine
Tidsramme: Baseline, after 10 weeks, after 24 weeks
The difference in the percent increase of the oxidative stress biomarker nitrotyrosine after stimulation with a standardized meal
Baseline, after 10 weeks, after 24 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Skin blood flow
Tidsramme: Baseline, after 10 weeks, after 24 weeks
Change in skin blood flow during stimulation by a standardized meal
Baseline, after 10 weeks, after 24 weeks
mRNA expression of proinflammatory cytokines (MAPK/eNOS, adiponectin, hsCRP, MMP-9)
Tidsramme: Baseline, after 10 weeks, after 24 weeks
Biomarkers of sub-clinical inflammation and cardiovascular risk: Change in Macrophage activation, MAPK/eNOS production levels, adiponectin and hsCRP (after test meal) from baseline to endpoint
Baseline, after 10 weeks, after 24 weeks
Insulin
Tidsramme: Baseline, after 10 weeks, after 24 weeks
Change in Insulin and the ratio from baseline to endpoint
Baseline, after 10 weeks, after 24 weeks
HbA1c
Tidsramme: Baseline, after 10 weeks, after 24 weeks
Blood glucose control: Change during test meal, HbA1c and FBG from baseline to endpoint
Baseline, after 10 weeks, after 24 weeks
Fasting blood glucose
Tidsramme: Baseline, after 10 weeks, after 24 weeks
Blood glucose control: Change during test meal, HbA1c and FBG from baseline to endpoint
Baseline, after 10 weeks, after 24 weeks
Hypoglycemic events
Tidsramme: Baseline, after 10 weeks, after 24 weeks
Incidence of hypoglycemia from baseline to endpoint
Baseline, after 10 weeks, after 24 weeks
intact Proinsulin
Tidsramme: Baseline, after 10 weeks, after 24 weeks
Change in intact Proinsulin and the ratio from baseline to endpoint
Baseline, after 10 weeks, after 24 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

ikfe-CRO GmbH

Samarbejdspartnere

IKFE Institute for Clinical Research and Development

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. september 2011

Primær færdiggørelse (Forventet)

1. maj 2012

Studieafslutning (Forventet)

1. maj 2012

Datoer for studieregistrering

Først indsendt

15. august 2011

Først indsendt, der opfyldte QC-kriterier

15. august 2011

Først opslået (Skøn)

16. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. marts 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. marts 2012

Sidst verificeret

1. marts 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • APIDR_L_05719

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 2 diabetes mellitus

Kliniske forsøg med Insulin glulisine

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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