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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Heidelberg University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00523393
First Posted: August 31, 2007
Last Update Posted: February 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heidelberg University
  Purpose
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.

Condition Intervention Phase
Type 2 Diabetes Drug: Insulin Glargin Drug: Human Insulin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 75
Study Start Date: August 2007
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Experimental: 2 Drug: Insulin Glargin
Titration of bedtime insulin glargin aiming at normal morning fasting glucose
Other Name: Lantus®, HOE901 (internal code number Sanofi-Aventis)
Active Comparator: 3 Drug: Human Insulin
Titration of bedtime human insulin aiming at normal morning fasting glucose
Other Name: Insuman Basal®, HR1799(internal code number Sanofi-Aventis)

  Eligibility

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523393


Contacts
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

Locations
Germany
University Clinics Heidelberg, Dept. Medicine1 Recruiting
Heidelberg, Germany, 69120
Contact: Dimitrios Oikonomou    +49 6221 56 ext 37944    dimitrios.oikonomou@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Per M Humpert, Dr. University of Heidelberg, Dept. Medicine 1, Germany
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Per M. Humpert, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00523393     History of Changes
Other Study ID Numbers: 2006-006573-24
First Submitted: August 29, 2007
First Posted: August 31, 2007
Last Update Posted: February 13, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs