Type 2 Diabetes
Conditions
Brief summary
In this trial, it will be studied whether early addition of the long acting insulin analogue Glargine is capable of increasing the number and differentiation of endothelial progenitor cells (EPC) in patients with type 2 diabetes, which can be seen as a marker of vascular regenerative potential and cardiovascular risk. In addition, the effect of Glargine on microvascular function will be studied. This will be done using laser Doppler measurements of the skin; in addition, MRI of the heart will be performed which is capable of quantifying the perfusion reserve of the myocardium and additional functional aspects of ventricular function. A beneficial effect of early addition of bedtime Glargine on EPC and vascular as well as myocardial function in this study might argue for a change in the therapeutic approach in type 2 diabetes and possibly improve the cardiovascular outcome in patients affected.
Interventions
DRUGInsulin Glargin
Titration of bedtime insulin glargin aiming at normal morning fasting glucose
DRUGHuman Insulin
Titration of bedtime human insulin aiming at normal morning fasting glucose
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 Diabetes * Oral antidiabetic therapy * Age 35 - 70 * 6,5%\< HbA1c ≤ 9% * Ability of subject to understand character and individual consequences of clinical trial * Written informed consent must be available before enrollment in the trial * For women with childbearing potential, adequate contraception (Pearl Index \< 1%, e.g. birth control pill) and negative blood pregnancy test * 6,5%\< HbA1c ≤ 9% * Ability of subject to understand character and individual consequences of clinical trial * Written informed consent must be available before enrollment in the trial * For women with childbearing potential, adequate contraception (Pearl Index \< 1%, e.g. birth control pill) and negative blood pregnancy test
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 * Insulin 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 |
|---|---|
| Change of number of circulating EPC 4 weeks after start of therapy compared to baseline as detected by FACS analysis | 4 weaks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Skin microvascular function (as measured by laser Doppler perfusion upon heat stimulation) | 4 months |
| Myocardial function and myocardial perfusion reserve as measured by MRI | 4 months |
| Intima-Media-Thickness | 4 months |
| Change of number of circulating EPC 4 as detected by in vitro outgrowth | 4 weeks, 4 months |
| Short-term Glucose control (fasting glucose) | 4 weeks, 4 months |
| Markers of inflammation and vascular risk in diabetes | 4 weeks, 4 months |
| Long-term Glucose control (HbA1c) | 4 weeks, 4 months |
Countries
Germany
Contacts
Primary ContactPer M Humpert, Dr.
Backup ContactDimitrios Oikonomou
Outcome results
None listed