Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments insulin glulisine, insulin aspart, regular human insulin
Phase phase 4
Sponsor ikfe-CRO GmbH
Collaborator IKFE Institute for Clinical Research and Development
Start date September 2011
End date May 2012
Trial size 12 participants
Trial identifier NCT01417897, APIDR_L_05719

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
insulin glulisine Apidra
Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.
(Active Comparator)
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.
insulin aspart NovoRapid
Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.
(Active Comparator)
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.
regular human insulin InsumanRapid
Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.

Primary Outcomes

Measure
Nitrotyrosine
time frame: Baseline, after 10 weeks, after 24 weeks

Secondary Outcomes

Measure
Skin blood flow
time frame: Baseline, after 10 weeks, after 24 weeks
mRNA expression of proinflammatory cytokines (MAPK/eNOS, adiponectin, hsCRP, MMP-9)
time frame: Baseline, after 10 weeks, after 24 weeks
Insulin
time frame: Baseline, after 10 weeks, after 24 weeks
HbA1c
time frame: Baseline, after 10 weeks, after 24 weeks
Fasting blood glucose
time frame: Baseline, after 10 weeks, after 24 weeks
Hypoglycemic events
time frame: Baseline, after 10 weeks, after 24 weeks
intact Proinsulin
time frame: Baseline, after 10 weeks, after 24 weeks

Eligibility Criteria

Male or female participants from 30 years up to 75 years old.

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

Additional Information

Official title Human Insulin Analogs: Evaluation of Inflammatory mRNA Expression of Macrophages and Endothelial Function of Short-acting Insulin - HERMES Pilot Study
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by ikfe-CRO GmbH.