Human Insulin Analogs: Evaluation of Inflammatory mRNA Expression of Macrophages and Endothelial Function of Short-acting Insulin - HERMES Pilot Study (HERMES)
2 mars 2012 uppdaterad av: 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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
12
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Rhineland-Palatinate
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Mainz, Rhineland-Palatinate, Tyskland, 55116
- ife GmbH, Clinic
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
30 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Dosage will be pro re nata.
Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.
Andra namn:
|
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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.
|
Dosage will be pro re nata.
Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.
Andra namn:
|
|
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.
|
Dosage will be pro re nata.
Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Nitrotyrosine
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Skin blood flow
Tidsram: Baseline, after 10 weeks, after 24 weeks
|
Change in skin blood flow during stimulation by a standardized meal
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Baseline, after 10 weeks, after 24 weeks
|
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mRNA expression of proinflammatory cytokines (MAPK/eNOS, adiponectin, hsCRP, MMP-9)
Tidsram: 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
|
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Insulin
Tidsram: Baseline, after 10 weeks, after 24 weeks
|
Change in Insulin and the ratio from baseline to endpoint
|
Baseline, after 10 weeks, after 24 weeks
|
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HbA1c
Tidsram: 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
Tidsram: 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
Tidsram: Baseline, after 10 weeks, after 24 weeks
|
Incidence of hypoglycemia from baseline to endpoint
|
Baseline, after 10 weeks, after 24 weeks
|
|
intact Proinsulin
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2011
Primärt slutförande (Förväntat)
1 maj 2012
Avslutad studie (Förväntat)
1 maj 2012
Studieregistreringsdatum
Först inskickad
15 augusti 2011
Först inskickad som uppfyllde QC-kriterierna
15 augusti 2011
Första postat (Uppskatta)
16 augusti 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
5 mars 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 mars 2012
Senast verifierad
1 mars 2012
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- APIDR_L_05719
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .