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Effect of Insulin Glulisine vs Regular Human Insulin on Postprandial Endothelial Function in Type 2 Diabetes

20. november 2007 opdateret af: IKFE Institute for Clinical Research and Development

Effect of Prandial Treatment With Insulin Glulisine Compared to Regular Human Insulin on Postprandial Endothelial Function and Microvascular Stress in Type 2 Diabetic Patients

The primary objective of the study is to evaluate the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin.

The secondary objectives are to evaluate the postprandial time course of the following efficacy parameters after injection of insulin glulisine compared with regular insulin on

  • Blood Glucose
  • Insulin
  • Intact proinsulin
  • Asymmetric dimethylarginine (ADMA)
  • Metal matrix proteasis (MMP-9)
  • Oxidative status (per ox)
  • Interleukin 18 (IL-18)
  • Free fatty acids (FFA)
  • Oxidised LDL (ox-LDL)
  • Microvascular blood circulation measured with laser Doppler at 37 °C (LDF37)
  • Microvascular blood circulation measured with laser Doppler at 44 °C (LDF44)

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Phase III b Indication Type 2 Diabetes Trial Objectives 1) Primary objective: The primary objective of the study is to evaluate the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin. 2) Secondary objectives: The secondary objectives are to evaluate the postprandial time course of blood glucose, insulin, intact proinsulin, asymmetric dimethylarginine (ADMA), metal matrix proteasis (MMP-9), free fatty acids (FFA), oxidised LDL (ox-LDL), oxidative status (per ox), IL-18 as well as postprandial time course of microvascular blood circulation measured with laserdopplerflux at 37 °C (LDF37) and 44 C (LDF44).

Efficacy Variables Primary efficacy variablePostprandial time course of nitrotyrosineSecondary efficacy variablePostprandial time course of glucose, insulin, intact proinsulin, ADMA, MMP-9, FFA, ox-LDL, per-ox, and IL-18 as well as postprandial time course of laserdopplerflux at 37 °C and 44 °C Safety Variables Incidence and frequency of adverse events and evaluation of safety laboratory parameters Medication/Dosage Insulin glulisine, dose 0.10 U/kg and Regular Human Insulin, dose 0.10 U/kg Study Duration Duration of study participation for one patient: 5 - 43 days Overall duration of the study: 6 months Design Single-centre, open label, randomized, 2-way-crossover trial Population Male and female type 2 diabetic patients between 40 and 70 years with HbA1c between 6.5 % and 9.9 % and treated with sulfonyurea alone or in combination with Metformin in a stable dosage within the last 3 months Sample Size N = 15

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Fase 3

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
        • Ikfe

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

40 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Type 2 Diabetes mellitus according to the ADA criteria
  2. HbA1c between 6.5 % and 9.9 %
  3. Monotherapy with sulfonylurea or combined with Metformin in a stable dosage within the last 3 months
  4. Age between 40 and 70 years
  5. BMI < 40

Exclusion Criteria:

  1. Type 1 Diabetes mellitus
  2. Pre-Treatment with insulin within the last 6 months prior to screening
  3. Treatment with glitazones within the last 6 months prior to screening
  4. Pre-Treatment with PPARy-agonists, glinides or glucosidase inhibitors within the last 4 weeks prior to screening
  5. Untreated hypertension stage II-III according to WHO criteria
  6. Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
  7. Total Cholesterol > 300 mg/dl (anamnestically)
  8. Hypokalemia (K < 3.5 mmol /l)
  9. Major micro- or macrovascular complications as judged by the investigator
  10. Tobacco use within the last 12 months prior to screening
  11. Drugs with major impact on endothelial function like nitrates etc.
  12. History of drug or alcohol abuse within the last five years prior to screening
  13. Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
  14. History of severe or multiple allergies
  15. Treatment with any other investigational drug within 3 months prior to screening
  16. Progressive fatal disease
  17. History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.1 mg/dL in women, > 1.5 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator
  18. Pregnancy or breast feeding
  19. 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 vasectomised partner
  20. 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: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
One Day Treatment with Insulin Glulisine
Medicin: Insulin Glulisine
100 IU/ml, 0.10 U/kg immediately before ingestion of a standardised liquid meal
Andre navne:
  • Apidra
Aktiv komparator: 2
One day Treatment with Human insulin
Medicin: Insulin
100 IU/ml, 0.10 U/kg 15 Minutes before ingestion of a standardised liquid meal
Andre navne:
  • Insuman

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin
Tidsramme: 1 day
1 day

Sekundære resultatmål

Resultatmål
Tidsramme
postprandial time course of blood glucose, insulin, intact proinsulin, ADMA, MMP-9, FFA, ox-LDL, per ox Status, IL-18, postprandial time course of microvascular blood circulation measured with laserdopplerflux at 37 °C and 44 C
Tidsramme: 1 day
1 day

Samarbejdspartnere og efterforskere

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

Sponsor

IKFE Institute for Clinical Research and Development

Efterforskere

  • Ledende efterforsker: Thomas A Forst, Prof, MD, 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. december 2006

Studieafslutning (Faktiske)

1. marts 2007

Datoer for studieregistrering

Først indsendt

20. november 2007

Først indsendt, der opfyldte QC-kriterier

20. november 2007

Først opslået (Skøn)

21. november 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. november 2007

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. november 2007

Sidst verificeret

1. november 2007

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • APIDR_L_01896
  • EudraCT Number 2006-005127-42

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 Diabetes mellitus

Kliniske forsøg med Insulin Glulisine

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Germany

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner