Patients with known history of type 2 Diabetes Mellitus longer than 6 months, who were treated by diet in combination with oral antidiabetic drugs (OADs) are to be included in the study.
Conditions
Interventions
Trade Name: Levemir
Product Name: Levemir (tradename)
Pharmaceutical Form: Injection*
INN or Proposed INN: Insulindetemir
CAS Number: 169148-63-4
Current Sponsor code: 151610/06
Other descriptive name
Sponsors
Dpt. of Internal Medicine, Medical University of Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients are recruited from the diabetes outpatient department of the department of Internal Medicine, Medical University Innsbruck. Patients’ inclusion criteria are the gender (female), the subject’s age (35 to 55 years), history of type 2 DM over 6 months and level of glycosylated hemoglobin (HbA1c) >7% despite pre-existing treatment with diet and OADs. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: To reduce the confounding effects of other cardiovascular risk factors often associated with type 2 DM, patients with inadequately controlled hypertension (blood pressure >135/85 mmHg), with hyperlipidemias other than the high triglyceride-low high-density lipoprotein (HDL) cholesterol diabetic dislipidemia, and with a history of cardiovascular disease and smoking are excluded from the study. Medical treatment of hypertension and dyslipidemia remains unchanged 6 weeks before recruitment and is continued during the study protocol. Acute infectious and inflammatory diseases, as well as hepatic, renal and cardiac failure are excluded by taking a careful history and performing physical and laboratory examinations. Also, breastfeeding and pregnant women are excluded from the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall goal of the present trial is to study the influence of insulin Levemir treatment on the endothelial function of patients with type 2 DM by noninvasive measurement of flow-mediated ndothelium-dependent dilation (EDD) of the brachial artery.;Secondary Objective: In addition, following plasma parameters will be investigated: lipid profile, plasma glucose, HbA1c, plasma insulin level, renal and hepatic parameters and C-reactive protein (CRP). ;Primary end point(s): After baseline measurement of EDD and routinely examined plasma parameters (see E.2.2), patients are randomly assigned to three groups: group 1 receiving NPH-insulin, group 2 receiving insulin Levemir and group 3 with diet and OADs. After a treatment period of 3 months, sonography scans as well as laboratory measurements are repeated during a routine examination at the diabetes outpatient department. All decisions on individual insulin treatment are left to the treating physician of the diabetes outpatient department, Department of Internal Medicine, Medical University Innsbruck, following established internal therapeutic regimens. | — |
Countries
Austria
Outcome results
None listed