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

NCT00523393 | Unknown Phase 4

• 1 other identifier: 2006-006573-24
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change of number of circulating EPC 4 weeks after start of therapy compared to baseline as detected by FACS analysis

  4 weaks of treatment

Secondary Outcomes (7)

• Change of number of circulating EPC 4 as detected by in vitro outgrowth

  4 weeks, 4 months

• Skin microvascular function (as measured by laser Doppler perfusion upon heat stimulation)

  4 months

• Myocardial function and myocardial perfusion reserve as measured by MRI

  4 months

• Intima-Media-Thickness

  4 months

• Long-term Glucose control (HbA1c)

  4 weeks, 4 months

Study Arms (3)

1

NO INTERVENTION

2

EXPERIMENTAL

Drug: Insulin Glargin

3

ACTIVE COMPARATOR

Drug: Human Insulin

Interventions

Insulin Glargin DRUG

Titration of bedtime insulin glargin aiming at normal morning fasting glucose

Also known as: Lantus®, HOE901 (internal code number Sanofi-Aventis)

2

Human Insulin DRUG

Titration of bedtime human insulin aiming at normal morning fasting glucose

Also known as: Insuman Basal®, HR1799(internal code number Sanofi-Aventis)

3

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes
• Oral antidiabetic therapy
• Age 35 - 70
• ,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
• ,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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

University Clinics Heidelberg, Dept. Medicine1

Heidelberg, 69120, Germany

RECRUITING

Related Publications (1)

• Oikonomou D, Kopf S, von Bauer R, Djuric Z, Cebola R, Sander A, Englert S, Vittas S, Hidmark A, Morcos M, Korosoglou G, Nawroth PP, Humpert PM. Influence of insulin and glargine on outgrowth and number of circulating endothelial progenitor cells in type 2 diabetes patients: a partially double-blind, randomized, three-arm unicenter study. Cardiovasc Diabetol. 2014 Oct 11;13:137. doi: 10.1186/s12933-014-0137-4.

  PMID: 25300286 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin

Study Officials

• Per M Humpert, Dr.

  University of Heidelberg, Dept. Medicine 1, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Per M Humpert, Dr.

CONTACT

+49 6221 56; per.humpert@med.uni-heidelberg.de

Dimitrios Oikonomou

CONTACT

+49 6221 56; dimitrios.oikonomou@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 29, 2007
• First Posted: August 31, 2007
• Study Start: August 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: May 1, 2010
• Last Updated: February 13, 2009

Record last verified: 2009-02

Locations

DE (1)