The medical disease that will be investigated is type 2, diabetes mellitus. The patients who will be investigated are between 35 and 70 years old and on oral antidiabetic therapy. MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: Lantus
Pharmaceutical Form: Solution for injection
Trade Name: Insuman basal
Pharmaceutical Form: Solution for injection
Sponsors
University Hospital of Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Type 2 Diabetes -Oral antidiabetic therapy -Age 35 – 70 -6,5%=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - MODY - Malignant disease - Hematopoietic disorders - Impairment of renal function (Serum creatinine > 1,5mg/dl) - autoimmune disease - treatment with immunosuppressive drugs - Psychiatric disease - Myocardial ischemia during previous 6 month - Acute coronary syndrome - pAVK IIb, III, IV (Fontaine-Ratschow) - Erythropoietin treatment - Glitazone treatment during two weeks before inclusion - Pregnancy and lactation - History of hypersensitivity to the investigational product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational product - participation in other clinical trials and observation period of competing trials, respectively - No subject will be allowed to enroll in this trial more than once
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -change of number of circulating EPC 4 weeks after start of therapy compared to baseline as detected by FACS analysis;Secondary Objective: -change of number of circulating EPC 4 as detected by in vitro outgrowth -skin microvascular function (as measured by laser Doppler perfusion upon heat stimulation) -Myocardial function and microperfusion as measured by MRI -intima-media-thickness -long-term glucose control (HbA1c) -short-term glucose control (fasting glucose) -markers of inflammation and vascular risk in diabetes ;Primary end point(s): -Change of number of circulating EPC 4 weeks after start of therapy compared to baseline as detected by FACS analysis | — |
Countries
Germany
Outcome results
None listed