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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

IKFE Institute for Clinical Research and Development

Information provided by (Responsible Party):

Marcus Borchert, ikfe-CRO GmbH

ClinicalTrials.gov Identifier:

NCT01417897

First received: August 15, 2011

Last updated: March 2, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 15, 2011
Last Updated Date	March 2, 2012
Start Date ^ICMJE	September 2011
Estimated Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 15, 2011)	Nitrotyrosine [ Time Frame: Baseline, after 10 weeks, after 24 weeks ] [ Designated as safety issue: No ] The difference in the percent increase of the oxidative stress biomarker nitrotyrosine after stimulation with a standardized meal
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01417897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 22, 2011)	Skin blood flow [ Time Frame: Baseline, after 10 weeks, after 24 weeks ] [ Designated as safety issue: No ] Change in skin blood flow during stimulation by a standardized meal mRNA expression of proinflammatory cytokines (MAPK/eNOS, adiponectin, hsCRP, MMP-9) [ Time Frame: Baseline, after 10 weeks, after 24 weeks ] [ Designated as safety issue: No ] 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 Insulin [ Time Frame: Baseline, after 10 weeks, after 24 weeks ] [ Designated as safety issue: No ] Change in Insulin and the ratio from baseline to endpoint HbA1c [ Time Frame: Baseline, after 10 weeks, after 24 weeks ] [ Designated as safety issue: No ] Blood glucose control: Change during test meal, HbA1c and FBG from baseline to endpoint Fasting blood glucose [ Time Frame: Baseline, after 10 weeks, after 24 weeks ] [ Designated as safety issue: No ] Blood glucose control: Change during test meal, HbA1c and FBG from baseline to endpoint Hypoglycemic events [ Time Frame: Baseline, after 10 weeks, after 24 weeks ] [ Designated as safety issue: Yes ] Incidence of hypoglycemia from baseline to endpoint intact Proinsulin [ Time Frame: Baseline, after 10 weeks, after 24 weeks ] [ Designated as safety issue: No ] Change in intact Proinsulin and the ratio from baseline to endpoint
Original Secondary Outcome Measures ^ICMJE (submitted: August 15, 2011)	Skin blood flow [ Time Frame: Baseline, after 10 weeks, after 24 weeks ] [ Designated as safety issue: No ] Change in skin blood flow during stimulation by a standardized meal mRNA expression of proinflammatory cytokines (MAPK/eNOS, adiponectin, hsCRP, MMP-9) [ Time Frame: Baseline, after 10 weeks, after 24 weeks ] [ Designated as safety issue: No ] 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 Insulin, intact Proinsulin [ Time Frame: Baseline, after 10 weeks, after 24 weeks ] [ Designated as safety issue: No ] Change in Insulin and intact Proinsulin and their ratio from baseline to endpoint HbA1c [ Time Frame: Baseline, after 10 weeks, after 24 weeks ] [ Designated as safety issue: No ] Blood glucose control: Change during test meal, HbA1c and FBG from baseline to endpoint Fasting blood glucose [ Time Frame: Baseline, after 10 weeks, after 24 weeks ] [ Designated as safety issue: No ] Blood glucose control: Change during test meal, HbA1c and FBG from baseline to endpoint Hypoglycemic events [ Time Frame: Baseline, after 10 weeks, after 24 weeks ] [ Designated as safety issue: Yes ] Incidence of hypoglycemia from baseline to endpoint
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Human Insulin Analogs: Evaluation of Inflammatory mRNA Expression of Macrophages and Endothelial Function of Short-acting Insulin - HERMES Pilot Study
Official Title ^ICMJE	Human Insulin Analogs: Evaluation of Inflammatory mRNA Expression of Macrophages and Endothelial Function of Short-acting Insulin - HERMES Pilot Study
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Type 2 Diabetes Mellitus
Intervention ^ICMJE	Drug: Insulin glulisine Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL. Other Name: Apidra Drug: Insulin aspart Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL. Other Name: NovoRapid Drug: Regular human insulin Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL. Other Name: InsumanRapid
Study Arm (s)	Experimental: 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. Intervention: Drug: Insulin glulisine Active Comparator: 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. Intervention: Drug: Insulin aspart Active Comparator: 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. Intervention: Drug: Regular human insulin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	12
Estimated Completion Date	May 2012
Estimated Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	30 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01417897
Other Study ID Numbers ^ICMJE	APIDR_L_05719
Has Data Monitoring Committee	No
Responsible Party	Marcus Borchert, ikfe-CRO GmbH
Study Sponsor ^ICMJE	ikfe-CRO GmbH
Collaborators ^ICMJE	IKFE Institute for Clinical Research and Development
Investigators ^ICMJE	Not Provided
Information Provided By	ikfe-CRO GmbH
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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