Diabetes Mellitus, Type 1Phase 3NCT00546702
Glulisine + Lantus in Type I Patients
A Phase 3 study testing Insuline Glulisine in people with Diabetes Mellitus, Type 1, run by Sanofi at 1 site in Russia.
Trial summary
To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus To evaluate the change in HbA1c at week 26, blood/glucose parameters, hypoglycemia… 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?
- Insuline Glulisine
- How many people
- 142 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2004to Feb 2005
- 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
- Adult men and women (>18 years) with type I diabetes mellitus (onset of diabetes under the age of 40)
- An HbA1c range of >6.5 - <11%
- And on multiple injection regimen (more than 1 year of continuous insulin treatment)
- Body mass index <35.
Who cannot join
- Active proliferative diabetic retinopathy
- Diabetes other than type I diabetes mellitus
- Pancreatectomised subjects
- Subjects who have undergone pancreas and or islet cell transplantats, requiring treatment with not permited drugs during the study, previous treatment (in the period not less than 1 month before the beginning of the trial) with insulin glargine
- Hypersensitivity to insulin
- Major systemic diseases
- Impaired hepatic or renal function
- 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: Multicenter, Open, Non-Randomised Phase III Clinical Study of Efficacy and Safety of Insulin Glulisine (HMR1964) Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine During 26 Weeks of Therapy
To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus To evaluate the change in HbA1c at week 26, blood/glucose parameters, hypoglycemia, insulin dose in subjects with type I diabetes mellitus receiving HMR 1964 and insulin glargine.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insuline Glulisine
- 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.
Insuline GlulisineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of HbA1c.
Measured: from baseline to endpoint.
Secondary outcomes (2)
Change in HbA1c.
Measured: from baseline (week 1) to weeks 12 and 26
Blood glucose parameters, hypoglycaemic episodes and dosage of the mealtime and basal insulins.
Measured: from baseline to endpoint.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startSep 2004
- Primary completionFeb 2005
- Study completionFeb 2005
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Olga Efremenkova, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546702
- Sponsor's protocol ID
- HMR1964A_3505
- Status last verified
- Jun 2009
- First submitted
- 18 Oct 2007
- Last updated
- 15 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open, Non-Randomised Phase III Clinical Study of Efficacy and Safety of Insulin Glulisine (HMR1964) Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine During 26 Weeks of Therapy
- ClinicalTrials.gov ID
- NCT00546702
- Acronym / sponsor ID
- HMR1964A_3505
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 19 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 evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus To evaluate the change in HbA1c at week 26, blood/glucose parameters, hypoglycemia, insulin dose in subjects with type I diabetes mellitus receiving HMR 1964 and insulin glargine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult men and women (>18 years) with type I diabetes mellitus (onset of diabetes under the age of 40)
- An HbA1c range of >6.5 - <11%
- And on multiple injection regimen (more than 1 year of continuous insulin treatment)
- Body mass index <35.
Key exclusion criteria (8 listed)
- Active proliferative diabetic retinopathy
- Diabetes other than type I diabetes mellitus
- Pancreatectomised subjects
- Subjects who have undergone pancreas and or islet cell transplantats, requiring treatment with not permited drugs during the study, previous treatment (in the period not less than 1 month before the beginning of the trial) with insulin glargine
- Hypersensitivity to insulin
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 |
|---|---|---|
| Insuline Glulisine | Drug | – |
Primary outcome
Change of HbA1c.
Time frame: from baseline to endpoint.
2 secondary outcomes
Change in HbA1c.
Time frame: from baseline (week 1) to weeks 12 and 26
Blood glucose parameters, hypoglycaemic episodes and dosage of the mealtime and basal insulins.
Time frame: from baseline to endpoint.
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 15 Jun 2009.
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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.
Olga Efremenkova 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 Insuline Glulisine in people with Diabetes Mellitus, Type 1, run by Sanofi at 1 site in Russia.
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 8 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 15 Jun 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 Russia. 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?
Change of HbA1c. (time frame: from baseline to endpoint.). 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 15 Jun 2009; AzTrials last refreshed its copy on 3 Nov 2026.