Diabetes Mellitus, Type 1Phase 3NCT00537251
32 Week, Open, Randomized, 2 Way Cross Over Multicentre Trial to Compare Safety & Efficacy of Combination of HOE901 Insulin Analogue Once Daily at Bedtime + Lispro Insulin Before Meals vs NPH Insulin (Twice a Day) + Regular in Type 1 Diabetes Mellitus
A Phase 3 study testing Insulin glargine in people with Diabetes Mellitus, Type 1, run by Sanofi.
Trial summary
To compare the efficacy (in terms of metabolic control evaluated through HbA1c levels) of treatment with insulin glargine as basal insulin and insulin analogue (insulin lispro) as mealtime insulin with a regimen of insulin NPH as basal insulin with regular insulin, as mealtime insulin, after a 16 week treatment phase… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Insulin glargine
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2001to Feb 2004
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with type 1 diabetes mellitus
- 18-65 years of age
- C-Peptide negative
- Treated at least for 6 months with multiple daily doses of insulin and with HbA1c greater than or equal to 7.0% and less than or equal to 9.5% and a BMI less than or equal to 35 kg/m².
- Women of childbearing potential must have a negative pregnancy test in visit 1 and must use an effective contraceptive method during the study.
Who cannot join
None listed.
About this study
Official title: 32-Week, Open, Randomized, Cross-Over, Local, Multicenter Clinical Trial Comparing Insulin Glargine in Combination With Insulin Analogue (Insulin Lispro) to NPH Insulin in Combination With Regular Insulin in Type 1 Diabetes Mellitus Patients in an Intensified Insulin Regimen.
To compare the efficacy (in terms of metabolic control evaluated through HbA1c levels) of treatment with insulin glargine as basal insulin and insulin analogue (insulin lispro) as mealtime insulin with a regimen of insulin NPH as basal insulin with regular insulin, as mealtime insulin, after a 16 week treatment phase with each regimen and to compare the safety of both treatments, evaluated through hypoglycemic rates.
Read the detailed description
Multicenter, open-label, randomized (allocation ratio 1:1), cross-over with two treatment phases of 16 weeks each in two treatment groups:
- Study arm with insulin glargine + insulin lispro (phase 1) and insulin NPH + regular insulin (phase 2)
- Insulin NPH + regular insulin (phase 1) and insulin glargine + insulin lispro (phase 2)
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insulin glargine
- 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 glargineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare efficacy of insulin glargine & short acting insulin (Lispro), NPH insulin regime as basal insulin and regular insulin for meal insulin for metabolic control, evaluated by means of HbA1c .
Measured: after 16 weeks of treatment with each treatment regime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startNov 2001
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jose Taboada Mosquera, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537251
- Sponsor's protocol ID
- HOE901_4023
- Status last verified
- Sep 2007
- First submitted
- 28 Sep 2007
- Last updated
- 1 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 32-Week, Open, Randomized, Cross-Over, Local, Multicenter Clinical Trial Comparing Insulin Glargine in Combination With Insulin Analogue (Insulin Lispro) to NPH Insulin in Combination With Regular Insulin in Type 1 Diabetes Mellitus Patients in an Intensified Insulin Regimen.
- ClinicalTrials.gov ID
- NCT00537251
- Acronym / sponsor ID
- HOE901_4023
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Study completion
- Feb 2004 (actual)
- First posted
- 1 Oct 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.
To compare the efficacy (in terms of metabolic control evaluated through HbA1c levels) of treatment with insulin glargine as basal insulin and insulin analogue (insulin lispro) as mealtime insulin with a regimen of insulin NPH as basal insulin with regular insulin, as mealtime insulin, after a 16 week treatment phase with each regimen and to compare the safety of both treatments, evaluated through hypoglycemic rates.
Detailed description
Multicenter, open-label, randomized (allocation ratio 1:1), cross-over with two treatment phases of 16 weeks each in two treatment groups:
- Study arm with insulin glargine + insulin lispro (phase 1) and insulin NPH + regular insulin (phase 2)
- Insulin NPH + regular insulin (phase 1) and insulin glargine + insulin lispro (phase 2)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with type 1 diabetes mellitus
- 18-65 years of age
- C-Peptide negative
- Treated at least for 6 months with multiple daily doses of insulin and with HbA1c greater than or equal to 7.0% and less than or equal to 9.5% and a BMI less than or equal to 35 kg/m².
- Women of childbearing potential must have a negative pregnancy test in visit 1 and must use an effective contraceptive method during the study.
Key exclusion criteria (0 listed)
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 glargine | Drug | – |
Primary outcome
Compare efficacy of insulin glargine & short acting insulin (Lispro), NPH insulin regime as basal insulin and regular insulin for meal insulin for metabolic control, evaluated by means of HbA1c .
Time frame: after 16 weeks of treatment with each treatment regime
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 1 Oct 2007.
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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.
Jose Taboada Mosquera study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin glargine in people with Diabetes Mellitus, Type 1, run by Sanofi.
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 5 inclusion and 0 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 1 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
Compare efficacy of insulin glargine & short acting insulin (Lispro), NPH insulin regime as basal insulin and regular insulin for meal insulin for metabolic control, evaluated by means of HbA1c . (time frame: after 16 weeks of treatment with each treatment regime). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2007.