Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells

Heidelberg University

Status and phase

Unknown

Phase 4

Conditions

Type 2 Diabetes

Treatments

Drug: Insulin Glargin

Drug: Human Insulin

Study type

Interventional

Funder types

Other

Identifiers

NCT00523393

2006-006573-24

Details and patient eligibility

About

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.

Enrollment

75 estimated patients

Sex

All

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

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.