Diabetes Mellitus, Type 2Phase 4NCT00335465
Lantus Effect on Myocardial Glucose Metabolism in T2
A Phase 4 study testing Insulin glargine in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Italy.
Trial summary
The primary objective of the present study is to assess changes of myocardial glucose uptake (MGU) during clamp studies using positron emission tomography (PET) scanning in patients with type 2 diabetes and idiopathic left ventricular dysfunction (LVD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin glargine
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2005to Jun 2008
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LV systolic dysfunction (2D-Echo LVEF < 50%) with or without LV dilation (2D-Echo LV EDD > 56 mm) or left ventricular end-diastolic diameter (LVEDD) >55mm with or without LV dysfunction
- angiographically normal coronary arteries (< 50% vessel narrowing);
- newly diagnosed type 2 diabetes;
- previously diagnosed: OAD treated type 2 diabetic patients able to take part in the study after a one-month wash-out period and insulin treated type 2 diabetic patients able to take part in the study after one week wash-out period.
Who cannot join
- evidence of congenital or valvular cardiac diseases, hypertrophic cardiomyopathy, overt heart failure (NYHA class III-IV);
- moderate to severe hypertension (diastolic aortic pressure > 100 mmHg);
- hypotension (systolic aortic pressure < 100 mmHg);
- nephropathy (serum creatinine > 3 mg/dL);
- other systemic and/or infective diseases;
- severe dyslipidemia;
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- peripheral vasculopathy;
- necessity of vasoactive medical treatment in the last 48 hours;
- atrial fibrillation;
- Refusal or impossibility to give written informed consent;
- patients diagnosed with type 1 insulin dependent diabetes;
- clinically relevant cardiovascular, hepatic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult;
- patients with medical history positive for cerebrovascular accidents, including Transient Ischaemic Attack (TIA);
- women who are lactating, pregnant, or planning to become pregnant during the study;
- history of hypersensitivity to the investigational products or to drugs with similar chemical structures;
- likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol;
- treatment with any investigational product in the last 30 days or 5 half-lives (whichever is longer) before study entry;
- current use of investigational agents or participation in any other investigational studies during study period;
- history of drug or alcohol abuse;
- impaired hepatic function, as shown by Alamine AminoTransferase (ALT) > 2,5 times the upper limit of the normal laboratory range;
- mental condition making the subject unable to understand the nature, scope, and possible consequences of the study;
- patients unable to understand dosing directions;
- subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study procedures;
- receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry;
- previous enrollment in the present study.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study for the Evaluation of the Effects of Insulin Treatment on Myocardial Function, Perfusion, and Glucose Metabolism in Patients With Primary Left Ventricular Dysfunction and Type 2 Diabetes.
The primary objective of the present study is to assess changes of myocardial glucose uptake (MGU) during clamp studies using positron emission tomography (PET) scanning in patients with type 2 diabetes and idiopathic left ventricular dysfunction (LVD).
The secondary objectives of the study are: assessment of changes of myocardial microcirculation at rest and during adenosine stimulation using PET; assessment of changes in myocardial structure and function evaluated by magnetic resonance imaging (MRI); assessment of glycaemic control by measurement of HbA1c, fasting blood glucose and insulin levels; assessment of safety (adverse event profile, laboratory data).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin glargine
- 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 glargineDrug
once a daily, sc injection, 100IU/ml
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of insulin treatment on myocardial function, perfusion and glucose metabolism.
Measured: assessed before and after treatment
adverse events
Measured: throughout the study
Secondary outcomes (1)
changes of myocardial structure and left ventricular systolic and diastolic function
Measured: at baseline and at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2006 (estimated)
- Study startSep 2005
- Primary completionJun 2008
- Study completionJun 2008
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Georges Paizis, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335465
- Sponsor's protocol ID
- HOE901_4053
- Other IDs
- EUDRACT # : 2004-002729-34
- Status last verified
- Dec 2009
- First submitted
- 8 Jun 2006
- Last updated
- 7 Dec 2009
- Results posted
- No
Publications
Masi S, Lautamaki R, Guiducci L, Di Cecco P, Porciello C, Pardini S, Morales MA, Chubuchny V, Salvadori PA, Emdin M, Sironi AM, Knuuti J, Neglia D, Nuutila P, Ferrannini E, Iozzo P. Similar patterns of myocardial metabolism and perfusion in patients with type 2 diabetes and heart disease of ischaemic and non-ischaemic origin. Diabetologia. 2012 Sep;55(9):2494-500. doi: 10.1007/s00125-012-2631-0. Epub 2012 Jul 1.
PubMed 22752026
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Evaluation of the Effects of Insulin Treatment on Myocardial Function, Perfusion, and Glucose Metabolism in Patients With Primary Left Ventricular Dysfunction and Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT00335465
- Acronym / sponsor ID
- HOE901_4053
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 9 Jun 2006 (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.
The primary objective of the present study is to assess changes of myocardial glucose uptake (MGU) during clamp studies using positron emission tomography (PET) scanning in patients with type 2 diabetes and idiopathic left ventricular dysfunction (LVD).
The secondary objectives of the study are: assessment of changes of myocardial microcirculation at rest and during adenosine stimulation using PET; assessment of changes in myocardial structure and function evaluated by magnetic resonance imaging (MRI); assessment of glycaemic control by measurement of HbA1c, fasting blood glucose and insulin levels; assessment of safety (adverse event profile, laboratory data).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- LV systolic dysfunction (2D-Echo LVEF < 50%) with or without LV dilation (2D-Echo LV EDD > 56 mm) or left ventricular end-diastolic diameter (LVEDD) >55mm with or without LV dysfunction
- angiographically normal coronary arteries (< 50% vessel narrowing);
- newly diagnosed type 2 diabetes;
- previously diagnosed: OAD treated type 2 diabetic patients able to take part in the study after a one-month wash-out period and insulin treated type 2 diabetic patients able to take part in the study after one week wash-out period.
Key exclusion criteria (26 listed)
- evidence of congenital or valvular cardiac diseases, hypertrophic cardiomyopathy, overt heart failure (NYHA class III-IV);
- moderate to severe hypertension (diastolic aortic pressure > 100 mmHg);
- hypotension (systolic aortic pressure < 100 mmHg);
- nephropathy (serum creatinine > 3 mg/dL);
- other systemic and/or infective diseases;
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 glargineonce a daily, sc injection, 100IU/ml | Drug | – |
Primary outcome
effect of insulin treatment on myocardial function, perfusion and glucose metabolism.
Time frame: assessed before and after treatment
adverse events
Time frame: throughout the study
1 secondary outcome
changes of myocardial structure and left ventricular systolic and diastolic function
Time frame: at baseline and at the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2009.
- Derived from this study: PubMed 22752026Masi S, Lautamaki R, Guiducci L, Di Cecco P, Porciello C, Pardini S, Morales MA, Chubuchny V, Salvadori PA, Emdin M, Sironi AM, Knuuti J, Neglia D, Nuutila P, Ferrannini E, Iozzo P. Similar patterns of myocardial metabolism and perfusion in patients with type 2 diabetes and heart disease of ischaemic and non-ischaemic origin. Diabetologia. 2012 Sep;55(9):2494-500. doi: 10.1007/s00125-012-2631-0. Epub 2012 Jul 1.
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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.
Georges Paizis, MD study director
Sanofi
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 glargine in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Italy.
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 4 inclusion and 26 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: finished, as of the sponsor's last update on 7 Dec 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of insulin treatment on myocardial function, perfusion and glucose metabolism. (time frame: assessed before and after treatment). The study lists 2 primary outcomes in all. 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 NCT00335465, 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 7 Dec 2009.