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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Heidelberg University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00523393
First received: August 29, 2007
Last updated: February 12, 2009
Last verified: February 2009

August 29, 2007
February 12, 2009
August 2007
December 2009   (final data collection date for primary outcome measure)
Change of number of circulating EPC 4 weeks after start of therapy compared to baseline as detected by FACS analysis [ Time Frame: 4 weaks of treatment ] [ Designated as safety issue: No ]
Change of number of circulating EPC 4 weeks after start of therapy compared to baseline as detected by FACS analysis [ Time Frame: 4 weaks of treatment ]
Complete list of historical versions of study NCT00523393 on ClinicalTrials.gov Archive Site
  • Change of number of circulating EPC 4 as detected by in vitro outgrowth [ Time Frame: 4 weeks, 4 months ] [ Designated as safety issue: No ]
  • Skin microvascular function (as measured by laser Doppler perfusion upon heat stimulation) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Myocardial function and myocardial perfusion reserve as measured by MRI [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Intima-Media-Thickness [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Long-term Glucose control (HbA1c) [ Time Frame: 4 weeks, 4 months ] [ Designated as safety issue: No ]
  • Short-term Glucose control (fasting glucose) [ Time Frame: 4 weeks, 4 months ] [ Designated as safety issue: No ]
  • Markers of inflammation and vascular risk in diabetes [ Time Frame: 4 weeks, 4 months ] [ Designated as safety issue: No ]
  • Change of number of circulating EPC 4 as detected by in vitro outgrowth [ Time Frame: 4 weeks, 4 months ]
  • Skin microvascular function (as measured by laser Doppler perfusion upon heat stimulation) [ Time Frame: 4 months ]
  • Myocardial function and myocardial perfusion reserve as measured by MRI [ Time Frame: 4 months ]
  • Intima-Media-Thickness [ Time Frame: 4 months ]
  • Long-term Glucose control (HbA1c) [ Time Frame: 4 weeks, 4 months ]
  • Short-term Glucose control (fasting glucose) [ Time Frame: 4 weeks, 4 months ]
  • Markers of inflammation and vascular risk in diabetes [ Time Frame: 4 weeks, 4 months ]
Not Provided
Not Provided
 
Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Type 2 Diabetes
  • Drug: Insulin Glargin
    Titration of bedtime insulin glargin aiming at normal morning fasting glucose
    Other Name: Lantus®, HOE901 (internal code number Sanofi-Aventis)
  • Drug: Human Insulin
    Titration of bedtime human insulin aiming at normal morning fasting glucose
    Other Name: Insuman Basal®, HR1799(internal code number Sanofi-Aventis)
  • No Intervention: 1
  • Experimental: 2
    Intervention: Drug: Insulin Glargin
  • Active Comparator: 3
    Intervention: Drug: Human Insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
May 2010
December 2009   (final data collection date for primary outcome measure)

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.
Both
35 Years to 70 Years
No
Contact: Per M Humpert, Dr. +49 6221 56 ext 8027 per.humpert@med.uni-heidelberg.de
Contact: Dimitrios Oikonomou +49 6221 56 ext 37944 dimitrios.oikonomou@med.uni-heidelberg.de
Germany
 
NCT00523393
2006-006573-24
No
Dr. Per M. Humpert, University of Heidelberg
Heidelberg University
Not Provided
Principal Investigator: Per M Humpert, Dr. University of Heidelberg, Dept. Medicine 1, Germany
Heidelberg University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP