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

NCT ID: NCT01417897

Last Updated: 2012-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-05-31

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Insulin glulisine

Intervention Type: DRUG

Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.

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.

Group Type: ACTIVE_COMPARATOR

Insulin aspart

Intervention Type: DRUG

Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.

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.

Group Type: ACTIVE_COMPARATOR

Regular human insulin

Intervention Type: DRUG

Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.

Interventions

Insulin glulisine

Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.

Intervention Type: DRUG

Insulin aspart

Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.

Intervention Type: DRUG

Regular human insulin

Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.

Intervention Type: DRUG

Other Intervention Names

Apidra; NovoRapid; InsumanRapid

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IKFE Institute for Clinical Research and Development

OTHER

Sponsor Role: collaborator

ikfe-CRO GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Marcus Borchert

Thomas Forst, MD PhD, ikfe GmbH, Clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ife GmbH, Clinic

Mainz, Rhineland-Palatinate, Germany

Countries

Germany

Other Identifiers

APIDR_L_05719

Identifier Type: -

Identifier Source: org_study_id