Diabetes Mellitus, Type 1Phase 3VARIABILITENCT00271284
Efficacy Study on the Control of Blood Glucose Concentration in Type 1 Diabetic Patients
A Phase 3 study testing insulin glulisine / insulin glargine and insulin glulisin / insulin detemir in people with Diabetes Mellitus, Type 1, run by Sanofi at 1 site in France.
Trial summary
·Main objective: To compare the variability of fasting capillary blood glucose concentration, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics. It is a non-inferiority study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- insulin glulisine / insulin glargine and insulin glulisin / insulin detemir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2005to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Belonging to a social security scheme or covered by such a scheme
- With type 1 diabetes (defined as a concentration of C-peptide < 0.1 nmol//l and a fasting blood glucose of >= 1.26 g/l), diagnosed not less than 5 years previously
- Treated for at least 6 months by intensive insulin treatment, following a basal-bolus system, using insulin glargine (Lantus®) as basal insulin. During the study, this insulin will administered in the evening
- Trained in the titration of prandial insulin (the dose of rapid insulin decided at each mealtime depending on the composition of the meal)
- With an HbA1c level of <= 8.5% at the inclusion visit
- Capable of checking their blood glucose concentration using the material supplied by the sponsor: blood glucose meter and patient notebook
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- Able to eat 3 regular daily meals on the days for recording the blood glucose cycle and similarly as much as possible on other days throughout the length of the study
- Able to continue their usual daily activities during the study
- Women of child-bearing potential should be using an effective method of contraception
- Fundal examination result less than a year old available
Who cannot join
- Recent history of severe hypoglycaemia (at least 2 events in the 6 months prior to inclusion)
- An episode of acidocetosis in the 3 months prior to inclusion
- Proliferating retinopathy, defined as having required treatment by surgery or photocoagulation, in the 6 months prior to visit 1, or non-stabilised (rapidly developing) retinopathy which may require photocoagulation or surgery
- Pancreatectomy
- Altered hepatic function (AST or ALT >= 2.5 x normal, in the initial measurements)
- Altered renal function (plasma creatinine > 1.5 mg/dl)
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- Acute infection
- Acute or chronic metabolic acidosis
- Gastroparesis
- History of cancer in the last 5 years
- Medically significant cardiovascular, hepatic, neurological or endocrine disease or any other significant disease making carrying out the protocol or interpreting the trial results difficult
- History of drug or alcohol abuse
- Subject likely to receive treatment during the trial which is not authorised in the protocol (see Section 6.2), in particular, treatment by corticosteroids whatever the route of administration or dose.
- Antidiabetic treatment by products other than those supplied within the framework of this study
- Treatment by another product undergoing development during the 3 months prior to inclusion in the trial
- Hypersensitivity to one of the study products (insulin glargine, insulin detemir, insulin glulisine) or to one of the excipients present in the insulin preparations, used in the study
- Working at night
- Pregnancy
- Breast-feeding
- Mental state making the subject incapable of understanding the objectives and possible consequences of the trial
- Subject unable to submit to the restrictions of the protocol (e.g. uncooperative, incapable of attending monitoring visits and probably incapable of finishing the trial)
- Subject deprived of his liberty because of an administrative or legal decision
- The investigator or any member of the team or close to the investigator directly implicated in the trial particularly assistant doctors, pharmacists, nurses, trial coordinator, etc.
- 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: A Crossover, Multicentre, Randomised Trial Comparing the Effect on the Control of Blood Glucose Concentration of Insulin Glargine and Insulin Detemir, Combined With Insulin Glulisine, Used as a Bolus, in Type 1 Diabetic Patients
·Main objective: To compare the variability of fasting capillary blood glucose concentration, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics. It is a non-inferiority study.
·Secondary objectives:
Read more
Efficacy:
- To compare the variability of blood glucose concentration before the evening meal, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics.
- To record the intra- and inter-daily variability using the MAGE and MODD indices [1,2,3,4]
- To compare the glycaemic profiles (7 points)
- To evaluate the HbA1c concentration, at the end of each period of treatment, weight change, the dose of insulin used and the number of daily injections.
Tolerance:
- To record undesirable events
- To evaluate the safety in use from the record of episodes of hypoglycaemia (symptomatic, diurnal, nocturnal, severe).
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- insulin glulisine / insulin glargine, insulin glulisin / insulin detemir
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin glulisine / insulin glargineDrug
insulin glargine administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00
insulin glulisin / insulin detemirDrug
insulin detemir administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Not described Receives: Drug: insulin glulisine / insulin glargine |
| II | Active comparator | Not described Receives: Drug: insulin glulisin / insulin detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy data : fasting blood glucose concentration
Measured: read daily during the last 2 months of each period
Secondary outcomes (1)
Tolerance data : undesirable events including episodes of hypoglycaemia
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2005 (estimated)
- Study startOct 2005
- Primary completionSep 2008
- Study completionSep 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 1Studies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marie SEBILLE, Dr, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271284
- Sponsor's protocol ID
- HMR1964A_3516
- Other IDs
- EudraCT #: 2005-002771-32
- Acronym
- VARIABILITE
- Status last verified
- Dec 2009
- First submitted
- 29 Dec 2005
- Last updated
- 7 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Renard E, Dubois-Laforgue D, Guerci B; Variability Study Group. Non-inferiority of insulin glargine versus insulin detemir on blood glucose variability in type 1 diabetes patients: a multicenter, randomized, crossover study. Diabetes Technol Ther. 2011 Dec;13(12):1213-8. doi: 10.1089/dia.2011.0063. Epub 2011 Aug 2.
PubMed 21810024
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
- A Crossover, Multicentre, Randomised Trial Comparing the Effect on the Control of Blood Glucose Concentration of Insulin Glargine and Insulin Detemir, Combined With Insulin Glulisine, Used as a Bolus, in Type 1 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00271284
- Acronym / sponsor ID
- VARIABILITE / HMR1964A_3516
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 30 Dec 2005 (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.
·Main objective: To compare the variability of fasting capillary blood glucose concentration, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics. It is a non-inferiority study.
·Secondary objectives:
Efficacy:
- To compare the variability of blood glucose concentration before the evening meal, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics.
- To record the intra- and inter-daily variability using the MAGE and MODD indices [1,2,3,4]
- To compare the glycaemic profiles (7 points)
- To evaluate the HbA1c concentration, at the end of each period of treatment, weight change, the dose of insulin used and the number of daily injections.
Tolerance:
- To record undesirable events
- To evaluate the safety in use from the record of episodes of hypoglycaemia (symptomatic, diurnal, nocturnal, severe).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: insulin glulisine / insulin glargine |
| II | Active comparator | Drug: insulin glulisin / insulin detemir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Belonging to a social security scheme or covered by such a scheme
- With type 1 diabetes (defined as a concentration of C-peptide < 0.1 nmol//l and a fasting blood glucose of >= 1.26 g/l), diagnosed not less than 5 years previously
- Treated for at least 6 months by intensive insulin treatment, following a basal-bolus system, using insulin glargine (Lantus®) as basal insulin. During the study, this insulin will administered in the evening
- Trained in the titration of prandial insulin (the dose of rapid insulin decided at each mealtime depending on the composition of the meal)
- With an HbA1c level of <= 8.5% at the inclusion visit
Key exclusion criteria (24 listed)
- Recent history of severe hypoglycaemia (at least 2 events in the 6 months prior to inclusion)
- An episode of acidocetosis in the 3 months prior to inclusion
- Proliferating retinopathy, defined as having required treatment by surgery or photocoagulation, in the 6 months prior to visit 1, or non-stabilised (rapidly developing) retinopathy which may require photocoagulation or surgery
- Pancreatectomy
- Altered hepatic function (AST or ALT >= 2.5 x normal, in the initial measurements)
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 glulisine / insulin glargineinsulin glargine administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00 | Drug | I |
| insulin glulisin / insulin detemirinsulin detemir administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00 | Drug | II |
Primary outcome
Efficacy data : fasting blood glucose concentration
Time frame: read daily during the last 2 months of each period
1 secondary outcome
Tolerance data : undesirable events including episodes of hypoglycaemia
Time frame: throughout 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 21810024Renard E, Dubois-Laforgue D, Guerci B; Variability Study Group. Non-inferiority of insulin glargine versus insulin detemir on blood glucose variability in type 1 diabetes patients: a multicenter, randomized, crossover study. Diabetes Technol Ther. 2011 Dec;13(12):1213-8. doi: 10.1089/dia.2011.0063. Epub 2011 Aug 2.
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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.
Marie SEBILLE, Dr 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 insulin glulisin / insulin detemir in people with Diabetes Mellitus, Type 1, run by Sanofi at 1 site in France.
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 10 inclusion and 24 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 France. 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?
Efficacy data : fasting blood glucose concentration (time frame: read daily during the last 2 months of each period). 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 NCT00271284, 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.