Back to results

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

Primary Purpose

Type 2 Diabetes

Status

Unknown status

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Insulin Glargin

Human Insulin

About this trial

This is an interventional prevention trial for Type 2 Diabetes

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Clinics Heidelberg, Dept. Medicine1Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Myocardial function and myocardial perfusion reserve as measured by MRI

Intima-Media-Thickness

Long-term Glucose control (HbA1c)

Short-term Glucose control (fasting glucose)

Markers of inflammation and vascular risk in diabetes

Full Information

NCT ID

NCT00523393

First Posted

August 29, 2007

Last Updated

February 12, 2009

Sponsor

Heidelberg University

1. Study Identification

Unique Protocol Identification Number

NCT00523393

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

August 2007 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Heidelberg University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Insulin Glargin

Other Intervention Name(s)

Lantus®, HOE901 (internal code number Sanofi-Aventis)

Intervention Description

Titration of bedtime insulin glargin aiming at normal morning fasting glucose

Intervention Type

Drug

Intervention Name(s)

Human Insulin

Other Intervention Name(s)

Insuman Basal®, HR1799(internal code number Sanofi-Aventis)

Intervention Description

Titration of bedtime human insulin aiming at normal morning fasting glucose

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

Time Frame

4 weeks, 4 months

Title

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

Time Frame

4 months

Title

Myocardial function and myocardial perfusion reserve as measured by MRI

Time Frame

4 months

Title

Intima-Media-Thickness

Time Frame

4 months

Title

Long-term Glucose control (HbA1c)

Time Frame

4 weeks, 4 months

Title

Short-term Glucose control (fasting glucose)

Time Frame

4 weeks, 4 months

Title

Markers of inflammation and vascular risk in diabetes

Time Frame

4 weeks, 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Per M Humpert, Dr.

Phone

+49 6221 56

Ext

8027

per.humpert@med.uni-heidelberg.de

First Name & Middle Initial & Last Name or Official Title & Degree

Dimitrios Oikonomou

Phone

+49 6221 56

Ext

37944

dimitrios.oikonomou@med.uni-heidelberg.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Per M Humpert, Dr.

Organizational Affiliation

University of Heidelberg, Dept. Medicine 1, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Clinics Heidelberg, Dept. Medicine1

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dimitrios Oikonomou

Phone

+49 6221 56

Ext

37944

dimitrios.oikonomou@med.uni-heidelberg.de

12. IPD Sharing Statement

Citations:

PubMed Identifier

25300286

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs