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
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Per M. Humpert, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00523393     History of Changes
Other Study ID Numbers: 2006-006573-24
Study First Received: August 29, 2007
Last Updated: February 12, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 30, 2014