Diabetes Mellitus, Type 2Phase 3NCT00272064
ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.
A Phase 3 study testing Insulin glulisine, Insulin glargine and Metformin 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 verify the superiority of Telecare program vs. standard SMBG program in terms of mean HbA1c value (- 0,5%) at end-point. The secondary objectives of the study are the assessment of: total daily dose of insulin, changes in glycaemic and lipid profile, frequency of… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin glulisine, Insulin glargine and Metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2005to May 2008
- Phase
- Phase 3
- 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
- Diagnosis of type 2 Diabetes Mellitus
- Patients treated with combined oral antidiabetic drugs(as fixed combination or simultaneous administration) or with metformin in monotherapy at maximal doses for at least 3 months
- Patients having BMI > 25 Kg/m2;
- Patients having a HbA1c ≥ 7.5 % and ≤ 11 %
- Female patients must be menopausal, surgically sterile, or using effective contraceptive measures;
- Female of childbearing potential must use effective contraceptive measures for at least 1 month prior to the entry into the study and should continue to use the same contraceptive method during the overall study period.
Who cannot join
- Patients diagnosed with type 1 insulin dependent Diabetes Mellitus;
- History of two or more severe hypoglycaemic episodes within the past 3 months or history of unawareness hypoglycaemia;
- Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation);
- Impaired renal function
- Impaired liver function
- History of hypersensitivity to insulin or insulin analogues or any of the excipients in the Insulin glulisine and Insulin glargine formulation
Show all 20Show fewer
- History of hypersensitivity to metformin;
- Pregnant or breast-feeding women, or women planning to become pregnant during the study;
- Failure to use adequate contraception (women of current reproductive potential only);
- Any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological or other major systemic diseases or infective diseases;
- History of drug or alcohol abuse within the last 2 years or current addiction to substances of abuse;
- Night shift workers;
- Receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry;
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study;
- Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol;
- Any disease or condition including abuse of illicit drugs, prescription medicines or alcohol that in the opinion of the investigator or sponsor may interfere with the completion of the study;
- Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study procedures;
- Subject is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol;
- Previous enrolment 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: Optimisation of Insulin Treatment of Type 2 Diabetes Mellitus by Telecare Assistance for Self Monitoring of Blood Glucose (SMBG).
- The primary objective of the present study is to verify the superiority of Telecare program vs. standard SMBG program in terms of mean HbA1c value (- 0,5%) at end-point.
- The secondary objectives of the study are the assessment of: total daily dose of insulin, changes in glycaemic and lipid profile, frequency of hypoglycaemias, changes in weight, health-related quality of life, cost-effectiveness of Telecare program vs. common ambulatory program; general safety (adverse event profile, other routine laboratory parameters).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin glulisine, Insulin glargine, Metformin
- 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 glulisineDrug
individualized, once daily, dose aiming at 2h post-prandial plasma glucose goal < 140 mg/dl (7.8 mmol/l) in the optimized treatment phase, since visit 3, subcutaneous
Insulin glargineDrug
individualized, once daily, dose to reach mean fasting plasma glucose (FPG) <= 126 mg/dl (7.0 mmol/l), since randomization, subcutaneous
MetforminDrug
1000 mg b.i.d, since the qualification phase, oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Telecare system Receives: Drug: Insulin glulisine; Drug: Insulin glargine; Drug: Metformin |
| 2 | Other | Self Monitoring Blood Glucose (SMBG)system. Receives: Drug: Insulin glulisine; Drug: Insulin glargine; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of glycosilated haemoglobin (HbA1c)
Measured: At least 12 weeks from baseline (visit 3)
Secondary outcomes (9)
Changes in fasting plasma glucose
Measured: At each visit
Changes in plasma insulin levels
Measured: At each visit
Change of Self-monitoring of Blood Glucose (SMBG)
Measured: for the total study duration
Mean Amplitude Glucose Excursion (MAGE)
Measured: for the total study duration
Change in lipid profile
Measured: V1 (screening) and V5 (end of treatment)
Body weight - Body Mass Index
Measured: V1 (screening), V3 (start of titration), V4 (after 12 weeks of treatment), V5 (end of treatment), V6 (end of follow-up)
Total daily dose of insulins (glargine and glulisine)
Measured: At each visit (starting from V2 for glargine and from V3 for glulisine)
Health related Quality of Life
Measured: V2 (start of titration), V4 (after 12 weeks of treatment), V5 (end of treatment)
Hypoglycemic episodes
Measured: for the total study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startOct 2005
- Primary completionMay 2008
- Study completionMay 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- PAIZIS GEORGES, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272064
- Sponsor's protocol ID
- HMR1964A_3514
- Other IDs
- EudraCT # : 2004-002731-62
- Status last verified
- Dec 2009
- First submitted
- 2 Jan 2006
- Last updated
- 7 Dec 2009
- Results posted
- No
Publications
Del Prato S, Nicolucci A, Lovagnini-Scher AC, Turco S, Leotta S, Vespasiani G; ELEONOR Study Group. Telecare Provides comparable efficacy to conventional self-monitored blood glucose in patients with type 2 diabetes titrating one injection of insulin glulisine-the ELEONOR study. Diabetes Technol Ther. 2012 Feb;14(2):175-82. doi: 10.1089/dia.2011.0163. Epub 2011 Oct 20.
PubMed 22013886
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
- Optimisation of Insulin Treatment of Type 2 Diabetes Mellitus by Telecare Assistance for Self Monitoring of Blood Glucose (SMBG).
- ClinicalTrials.gov ID
- NCT00272064
- Acronym / sponsor ID
- HMR1964A_3514
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 4 Jan 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 verify the superiority of Telecare program vs. standard SMBG program in terms of mean HbA1c value (- 0,5%) at end-point.
- The secondary objectives of the study are the assessment of: total daily dose of insulin, changes in glycaemic and lipid profile, frequency of hypoglycaemias, changes in weight, health-related quality of life, cost-effectiveness of Telecare program vs. common ambulatory program; general safety (adverse event profile, other routine laboratory parameters).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Insulin glulisine, Drug: Insulin glargine, Drug: MetforminTelecare system |
| 2 | Other | Drug: Insulin glulisine, Drug: Insulin glargine, Drug: MetforminSelf Monitoring Blood Glucose (SMBG)system. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of type 2 Diabetes Mellitus
- Patients treated with combined oral antidiabetic drugs(as fixed combination or simultaneous administration) or with metformin in monotherapy at maximal doses for at least 3 months
- Patients having BMI > 25 Kg/m2;
- Patients having a HbA1c ≥ 7.5 % and ≤ 11 %
- Female patients must be menopausal, surgically sterile, or using effective contraceptive measures;
Key exclusion criteria (20 listed)
- Patients diagnosed with type 1 insulin dependent Diabetes Mellitus;
- History of two or more severe hypoglycaemic episodes within the past 3 months or history of unawareness hypoglycaemia;
- Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation);
- Impaired renal function
- Impaired liver function
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 glulisineindividualized, once daily, dose aiming at 2h post-prandial plasma glucose goal < 140 mg/dl (7.8 mmol/l) in the optimized treatment phase, since visit 3, subcutaneous | Drug | 1, 2 |
| Insulin glargineindividualized, once daily, dose to reach mean fasting plasma glucose (FPG) <= 126 mg/dl (7.0 mmol/l), since randomization, subcutaneous | Drug | 1, 2 |
| Metformin1000 mg b.i.d, since the qualification phase, oral | Drug | 1, 2 |
Primary outcome
Changes of glycosilated haemoglobin (HbA1c)
Time frame: At least 12 weeks from baseline (visit 3)
9 secondary outcomes
Changes in fasting plasma glucose
Time frame: At each visit
Changes in plasma insulin levels
Time frame: At each visit
Change of Self-monitoring of Blood Glucose (SMBG)
Time frame: for the total study duration
Mean Amplitude Glucose Excursion (MAGE)
Time frame: for the total study duration
Change in lipid profile
Time frame: V1 (screening) and V5 (end of treatment)
Body weight - Body Mass Index
Time frame: V1 (screening), V3 (start of titration), V4 (after 12 weeks of treatment), V5 (end of treatment), V6 (end of follow-up)
Total daily dose of insulins (glargine and glulisine)
Time frame: At each visit (starting from V2 for glargine and from V3 for glulisine)
Health related Quality of Life
Time frame: V2 (start of titration), V4 (after 12 weeks of treatment), V5 (end of treatment)
Hypoglycemic episodes
Time frame: for the total study duration
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 22013886Del Prato S, Nicolucci A, Lovagnini-Scher AC, Turco S, Leotta S, Vespasiani G; ELEONOR Study Group. Telecare Provides comparable efficacy to conventional self-monitored blood glucose in patients with type 2 diabetes titrating one injection of insulin glulisine-the ELEONOR study. Diabetes Technol Ther. 2012 Feb;14(2):175-82. doi: 10.1089/dia.2011.0163. Epub 2011 Oct 20.
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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.
PAIZIS GEORGES, 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 3 study testing Insulin glulisine, Insulin glargine and Metformin 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 6 inclusion and 20 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Changes of glycosilated haemoglobin (HbA1c) (time frame: At least 12 weeks from baseline (visit 3)). 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 NCT00272064, 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.