Prospective influence of bedtime insulin glargine on mobilization and function of endothelial progenitor cells in patients with type 2 diabetes: a partially double-blind, randomized, three-arm unicenter study - Glargine and EPC

• Conditions: 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: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2006-006573-24-DE
• Lead Sponsor: niversity Hospital of Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-01
• Last Update Posted: 6 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified