Type 2 DiabetesPhase 4NCT00523393
Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells
A Phase 4 study testing Insulin Glargin and Human Insulin in people with Type 2 Diabetes, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Insulin Glargin and Human Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2007to May 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- MODY
- Malignant disease
- Hematopoietic disorders
- Impairment of renal function (Serum creatinine > 1,5mg/dl)
- autoimmune disease
- treatment with immunosuppressive drugs
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Clinics Heidelberg, Dept. Medicine1
Heidelberg, 69120
Dimitrios Oikonomou, +49 6221 56 ext. 37944, dimitrios.oikonomou@med.uni-heidelberg.de
About this study
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
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
- Being tested
- Insulin Glargin, Human Insulin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin GlarginDrug
Also called Lantus®, HOE901 (internal code number Sanofi-Aventis)
Titration of bedtime insulin glargin aiming at normal morning fasting glucose
Human InsulinDrug
Also called Insuman Basal®, HR1799(internal code number Sanofi-Aventis)
Titration of bedtime human insulin aiming at normal morning fasting glucose
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Experimental | Not described Receives: Drug: Insulin Glargin |
| 3 | Active comparator | Not described Receives: Drug: Human Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of number of circulating EPC 4 weeks after start of therapy compared to baseline as detected by FACS analysis
Measured: 4 weaks of treatment
Secondary outcomes (7)
Change of number of circulating EPC 4 as detected by in vitro outgrowth
Measured: 4 weeks, 4 months
Skin microvascular function (as measured by laser Doppler perfusion upon heat stimulation)
Measured: 4 months
Myocardial function and myocardial perfusion reserve as measured by MRI
Measured: 4 months
Intima-Media-Thickness
Measured: 4 months
Long-term Glucose control (HbA1c)
Measured: 4 weeks, 4 months
Short-term Glucose control (fasting glucose)
Measured: 4 weeks, 4 months
Markers of inflammation and vascular risk in diabetes
Measured: 4 weeks, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2009 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Per M Humpert, Dr., Principal investigator, University of Heidelberg, Dept. Medicine 1, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523393
- Sponsor's protocol ID
- 2006-006573-24
- Status last verified
- Feb 2009
- First submitted
- 29 Aug 2007
- Last updated
- 13 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25300286
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00523393
- Acronym / sponsor ID
- 2006-006573-24
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 31 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Experimental | Drug: Insulin Glargin |
| 3 | Active comparator | Drug: Human Insulin |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- MODY
- Malignant disease
- Hematopoietic disorders
- Impairment of renal function (Serum creatinine > 1,5mg/dl)
- autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin GlarginAlso: Lantus®, HOE901 (internal code number Sanofi-Aventis)Titration of bedtime insulin glargin aiming at normal morning fasting glucose | Drug | 2 |
| Human InsulinAlso: Insuman Basal®, HR1799(internal code number Sanofi-Aventis)Titration of bedtime human insulin aiming at normal morning fasting glucose | Drug | 3 |
Primary outcome
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
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2009.
- Derived from this study: PubMed 25300286Oikonomou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per M Humpert, Dr. principal investigator
University of Heidelberg, Dept. Medicine 1, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin Glargin and Human Insulin in people with Type 2 Diabetes, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Per M Humpert, Dr. (+49 6221 56 ext. 8027, per.humpert@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00523393, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2009.