Diabetes mellitus Type 2 MedDRA version: 8.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Trade Name: Apidra® 100 E/ml
Product Name: Apidra®, Insulinglulisin
Pharmaceutical Form: Injection*
Other descriptive name: INSULIN GLULISINE
Concentration unit: IU/ml international unit(s)/millilitre
Sponsors
Institut für Klinische Forschung und Entwicklung (ikfe) GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 2 Diabetes mellitus according to ADA criteria 2. HbA1c between 6.5 % and 9.9 % 3. Monotherapy with sulfonylurea or combined with Metformin in a stable dosage within the last 3 months 4. Age between 40 and 70 years 5. BMI =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Type 1 Diabetes mellitus 2. Pre-Treatment with insulin within the last 6 months prior to screening 3. Treatment with glitazones within the last 6 months prior to screening 4. Pre-Treatment with PPARy-agonists, glinids or glucosidase inhibitors within the last 4 weeks prior to screening 5. Untreated hypertension stage II-III according to WHO criteria 6. Planned or anticipated change in antidiabetic and/or concomitant medication during study participation 7. Total Cholesterol > 300 mg/dl (anamnestically) 8. Hypocalemia (K 3 times the normal reference range), renal (creatinine > 1.1 mg/dL in women and > 1.5 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator 18. Pregnancy or breast feeding 19. 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 vasectomised partner 20. Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin. ;Secondary Objective: The secondary objectives are to evaluate the postprandial time course of blood glucose, insulin, intact proinsulin, asymmetric dimethylarginine (ADMA), metal matrix proteasis (MMP-9), free fatty acids (FFA), oxidised LDL (ox-LDL), oxidative status (per ox), IL-18 as well as postprandial time course of microvascular blood circulation measured with laserdopplerflux at 37 °C (LDF37) and 44 °C (LDF44). ;Primary end point(s): The primary end point is the timecourse of nitrotyrosine after prandial treatment with regular human insulin or insulinglulisine. | — |
Countries
Germany
Outcome results
None listed