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

NCT01417897 | Unknown Phase 4

• 1 other identifier: APIDR_L_05719
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Nitrotyrosine

  The difference in the percent increase of the oxidative stress biomarker nitrotyrosine after stimulation with a standardized meal

  Baseline, after 10 weeks, after 24 weeks

Secondary Outcomes (7)

• Skin blood flow

  Baseline, after 10 weeks, after 24 weeks

• mRNA expression of proinflammatory cytokines (MAPK/eNOS, adiponectin, hsCRP, MMP-9)

  Baseline, after 10 weeks, after 24 weeks

• Insulin

  Baseline, after 10 weeks, after 24 weeks

• HbA1c

  Baseline, after 10 weeks, after 24 weeks

• Fasting blood glucose

  Baseline, after 10 weeks, after 24 weeks

Study Arms (3)

Insulin Glulisine: bolus injections before each main meal

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.

Drug: Insulin glulisine

Insulin Aspart: bolus injections before each main meal

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.

Drug: Insulin aspart

Regular human insulin:bolus injections before each main meal

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.

Drug: Regular human insulin

Interventions

Insulin glulisine DRUG

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

Also known as: Apidra

Insulin Glulisine: bolus injections before each main meal

Insulin aspart DRUG

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

Also known as: NovoRapid

Insulin Aspart: bolus injections before each main meal

Regular human insulin DRUG

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

Also known as: InsumanRapid

Regular human insulin:bolus injections before each main meal

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ikfe-CRO GmbH: lead
• IKFE Institute for Clinical Research and Development: collaborator

Study Sites (1)

ife GmbH, Clinic

Mainz, Rhineland-Palatinate, 55116, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin glulisine; Insulin Aspart; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thomas Forst, MD PhD, ikfe GmbH, Clinic

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 16, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 5, 2012

Record last verified: 2012-03

Locations

DE (1)