Clinical trial NCT01417897: Human Insulin Analogs: Evaluation of Inflammatory mRNA Expression of Macrophages and Endothelial Function of Short-acting Insulin - HERMES Pilot Study
Official title: Human Insulin Analogs: Evaluation of Inflammatory mRNA Expression of Macrophages and Endothelial Function of Short-acting Insulin - HERMES Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: ikfe-CRO GmbH
Sponsor class: INDUSTRY
Collaborators: name: IKFE Institute for Clinical Research and Development
First posted: 2011-08-16
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Nitrotyrosine
timeFrame: Baseline, after 10 weeks, after 24 weeks
Secondary outcomes:
measure: Skin blood flow
timeFrame: Baseline, after 10 weeks, after 24 weeks
measure: mRNA expression of proinflammatory cytokines (MAPK/eNOS, adiponectin, hsCRP, MMP-9)
timeFrame: Baseline, after 10 weeks, after 24 weeks
measure: Insulin
timeFrame: Baseline, after 10 weeks, after 24 weeks
measure: HbA1c
timeFrame: Baseline, after 10 weeks, after 24 weeks
measure: Fasting blood glucose
timeFrame: Baseline, after 10 weeks, after 24 weeks
measure: Hypoglycemic events
timeFrame: Baseline, after 10 weeks, after 24 weeks
measure: intact Proinsulin
timeFrame: Baseline, after 10 weeks, after 24 weeks
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: ife GmbH, Clinic
state: Rhineland-Palatinate
Study officials:
References: