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

IKFE Institut für klinische Forschung und Entwicklung

Status and phase: Unknown; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Insulin glulisine; Drug: Insulin aspart; Drug: Regular human insulin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01417897

APIDR_L_05719

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Insulin Glulisine: bolus injections before each main meal

Experimental group

Description:

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.

Treatment:

Drug: Insulin glulisine

Insulin Aspart: bolus injections before each main meal

Active Comparator group

Description:

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.

Treatment:

Drug: Insulin aspart

Regular human insulin:bolus injections before each main meal

Active Comparator group

Description:

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.

Treatment:

Drug: Regular human insulin