Diabetes Mellitus, Type 1Phase 4NCT01202474
Apidra Children & Adolescents Study
A Phase 4 study testing INSULIN GLULISINE and INSULIN GLARGINE in people with Diabetes Mellitus, Type 1, run by Sanofi at 1 site in Russia.
Trial summary
Primary Objective: Evaluate the percentage of patients achieving glycosylated hemoglobin (HbA1c) level < 8% (in patients of 6-12 years old) and HbA1c level < 7.5% (in patients of 13-17 year old) at 6 and 12 months of treatment Secondary Objectives: Change in HbA1c level at 6 and 12 months of treatment Monthly rate of… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- INSULIN GLULISINE and INSULIN GLARGINE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- May 2011to Oct 2012
- Phase
- Phase 4
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ChildrenAdolescents with Type 1 diabetes Mellitus l(T1DM) onger than 1 year duration
- Age 6 -17 y.o.
- With 8%<HbA1c <10%
- Treated with insulin glargine and any rapid insulin
- Ability to perform a self blood-glucose monitoring (SBGM)
- Signed Informed consent.
Who cannot join
- Diabetes Mellitus type 2
- ChildrenAdolescents with Type 1 diabetes Mellitus previously treated with Apidra
- Hypersensitivity to Insulin glulisine
- Pregnant or lactation women
- Gestational diabetes mellitus
- Treatment with systemic corticosteroids in the 1 month prior to study entry
- T1DM complications: such as already existing active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the 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: A Study of Effectiveness and Safety of Apidra in Combination With Lantus Therapy in Basal-bolus Insulin Regimen in Inadequately Controlled Children and Adolescents With Type 1 Diabetes in the Russian Federation.
Primary Objective:
Evaluate the percentage of patients achieving glycosylated hemoglobin (HbA1c) level < 8% (in patients of 6-12 years old) and HbA1c level < 7.5% (in patients of 13-17 year old) at 6 and 12 months of treatment
Secondary Objectives:
Change in HbA1c level at 6 and 12 months of treatment Monthly rate of hypoglycaemia/per patient from the baseline to the end of the study Change in daily dose of glargine and glulisine at 6 and 12 months of treatment.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- INSULIN GLULISINE, 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 GLULISINEDrug
Also called Apidra
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once a day
INSULIN GLARGINEDrug
Also called Lantus
Pharmaceutical form:solution for injection Route of administration: subcutaneous Dose regimen: 0-15 minutes before meal or within 20 minutes from the start of meal according to prandial plasma glucose values
| Study group | Role | What they receive |
|---|---|---|
| insulin glulisine and insulin glargine | Experimental | insulin glulisine and insulin glargine basal/bolus regimen in accordance with the summary of product characteristics and titrated to Plasma glucose target as defined by American Diabetes Association (ADA) recommendations age-specific goals (12) Receives: Drug: INSULIN GLULISINE; Drug: INSULIN GLARGINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving HbA1c level < 8% (in patients 6-12 year-old) and HbA1c level < 7.5 % (in patients 13-17 year-old)
Measured: at 6 and 12 months of treatment
Secondary outcomes (3)
Change in HbA1c plasma level
Measured: at 6 and 12 months of treatment
Monthly rate of hypoglycaemia
Measured: from baseline to 12 months of treatment (study cut off)
Change in daily dose of glargine and glulisine
Measured: at 6 and 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startMay 2011
- Primary completionOct 2012
- Study completionOct 2012
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202474
- Sponsor's protocol ID
- APIDR_L_04884
- Other IDs
- U1111-1116-8645
- Status last verified
- Dec 2012
- First submitted
- 14 Sep 2010
- Last updated
- 18 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Effectiveness and Safety of Apidra in Combination With Lantus Therapy in Basal-bolus Insulin Regimen in Inadequately Controlled Children and Adolescents With Type 1 Diabetes in the Russian Federation.
- ClinicalTrials.gov ID
- NCT01202474
- Acronym / sponsor ID
- APIDR_L_04884
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Sep 2010 (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.
Primary Objective:
Evaluate the percentage of patients achieving glycosylated hemoglobin (HbA1c) level < 8% (in patients of 6-12 years old) and HbA1c level < 7.5% (in patients of 13-17 year old) at 6 and 12 months of treatment
Secondary Objectives:
Change in HbA1c level at 6 and 12 months of treatment Monthly rate of hypoglycaemia/per patient from the baseline to the end of the study Change in daily dose of glargine and glulisine at 6 and 12 months of treatment.
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 and insulin glargine | Experimental | Drug: INSULIN GLULISINE, Drug: INSULIN GLARGINEinsulin glulisine and insulin glargine basal/bolus regimen in accordance with the summary of product characteristics and titrated to Plasma glucose target as defined by American Diabetes Association (ADA) recommendations age-specific goals (12) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- ChildrenAdolescents with Type 1 diabetes Mellitus l(T1DM) onger than 1 year duration
- Age 6 -17 y.o.
- With 8%<HbA1c <10%
- Treated with insulin glargine and any rapid insulin
- Ability to perform a self blood-glucose monitoring (SBGM)
Key exclusion criteria (8 listed)
- Diabetes Mellitus type 2
- ChildrenAdolescents with Type 1 diabetes Mellitus previously treated with Apidra
- Hypersensitivity to Insulin glulisine
- Pregnant or lactation women
- Gestational diabetes mellitus
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 GLULISINEAlso: ApidraPharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once a day | Drug | insulin glulisine and insulin glargine |
| INSULIN GLARGINEAlso: LantusPharmaceutical form:solution for injection Route of administration: subcutaneous Dose regimen: 0-15 minutes before meal or within 20 minutes from the start of meal according to prandial plasma glucose values | Drug | insulin glulisine and insulin glargine |
Primary outcome
Percentage of patients achieving HbA1c level < 8% (in patients 6-12 year-old) and HbA1c level < 7.5 % (in patients 13-17 year-old)
Time frame: at 6 and 12 months of treatment
3 secondary outcomes
Change in HbA1c plasma level
Time frame: at 6 and 12 months of treatment
Monthly rate of hypoglycaemia
Time frame: from baseline to 12 months of treatment (study cut off)
Change in daily dose of glargine and glulisine
Time frame: at 6 and 12 months of treatment
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 Dec 2012.
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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.
Clinical Sciences & Operations 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 4 study testing INSULIN GLULISINE and INSULIN GLARGINE 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 6 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 18 Dec 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Percentage of patients achieving HbA1c level < 8% (in patients 6-12 year-old) and HbA1c level < 7.5 % (in patients 13-17 year-old) (time frame: at 6 and 12 months of treatment). 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 Dec 2012.