Diabetes Mellitus, Type 1Phase 3NCT00397553
Insulin Glulisine, Diabetes Mellitus Type 1
A Phase 3 study testing Insulin glulisine in people with Diabetes Mellitus, Type 1, run by Sanofi at 1 site in Russia.
Trial summary
To provide local data on efficacy and safety of insulin glulisine in patients with Type 1 Diabetes Mellitus receiving insulin glargine as basic insulin therapy 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2005to Dec 2007
- 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
- Diabetes mellitus, Type 1
- HbA1c 6.5-11.0%
- BMI <35 kg/m²
Who cannot join
- Diabetes mellitus, Type 2
- 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 Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine
To provide local data on efficacy and safety of insulin glulisine in patients with Type 1 Diabetes Mellitus receiving insulin glargine as basic insulin therapy
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insulin 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.
Insulin glulisineDrug
| Study group | Role | What they receive |
|---|---|---|
| Insulin Glulisine | Experimental | Not described Receives: Drug: Insulin glulisine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 52 weeks
Secondary outcomes (5)
HbA1c
Measured: 26 weeks
Fasting Blood Glucose
Measured: 26 weeks
Fasting Blood Glucose
Measured: 52 weeks
Post-prandial glycemia (2 hour after breakfast)
Measured: 26 weeks
Post-prandial glycemia (2 hour after breakfast)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startJan 2005
- Primary completionDec 2007
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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marina Atarshchikova, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397553
- Sponsor's protocol ID
- HMR1964A_3517
- Status last verified
- May 2009
- First submitted
- 8 Nov 2006
- Last updated
- 18 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 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 Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine
- ClinicalTrials.gov ID
- NCT00397553
- Acronym / sponsor ID
- HMR1964A_3517
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Dec 2007 (actual)
- First posted
- 9 Nov 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.
To provide local data on efficacy and safety of insulin glulisine in patients with Type 1 Diabetes Mellitus receiving insulin glargine as basic insulin therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin Glulisine | Experimental | Drug: Insulin glulisine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diabetes mellitus, Type 1
- HbA1c 6.5-11.0%
- BMI <35 kg/m²
Key exclusion criteria (2 listed)
- Diabetes mellitus, Type 2
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 | Drug | Insulin Glulisine |
Primary outcome
HbA1c
Time frame: 52 weeks
5 secondary outcomes
HbA1c
Time frame: 26 weeks
Fasting Blood Glucose
Time frame: 26 weeks
Fasting Blood Glucose
Time frame: 52 weeks
Post-prandial glycemia (2 hour after breakfast)
Time frame: 26 weeks
Post-prandial glycemia (2 hour after breakfast)
Time frame: 52 weeks
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 18 Sep 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.
Marina Atarshchikova, 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 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 3 inclusion and 2 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 18 Sep 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?
HbA1c (time frame: 52 weeks). 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 18 Sep 2009.