Status:
UNKNOWN
Human Insulin Analogs: Evaluation of Inflammatory mRNA Expression of Macrophages and Endothelial Function of Short-acting Insulin - HERMES Pilot Study
Lead Sponsor:
ikfe-CRO GmbH
Collaborating Sponsors:
IKFE Institute for Clinical Research and Development
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01417897
Start Date
September 1 2011
End Date
May 1 2012
Last Update
March 5 2012
Active Locations (1)
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1
ife GmbH, Clinic
Mainz, Rhineland-Palatinate, Germany, 55116