Diabetes Mellitus, Type 1Phase 3NCT01194882
Benefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes
A Phase 3 study testing HUMAN INSULIN (BIOSYNTHETIC) and Insuplant in people with Diabetes Mellitus, Type 1, run by Sanofi at 17 sites in 4 countries.
Trial summary
Primary Objective: To compare Insuman Implantable 400 IU/ml versus Insuplant 400 IU/ml with respect to the pump refill accuracy during a 4 refill cycle period (i.e. the comparative phase); To assess efficacy measured by hemoglobin glycosylated (HBA1c) change in Insuman Implantable 400 IU/ml group versus Insuplant 400… 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?
- HUMAN INSULIN (BIOSYNTHETIC) and Insuplant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 479 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 16 Nov 2010to 1 Feb 2018
- 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
- Patients already treated with Insuplant 400 IU/ml via a Medtronic Implantable System 2007
- Glycosylated hemoglobin ≤9.0%
- Patient showing a percentage of error at refill equal or below 20%
- Patient undergoing NaOH rinse procedure of at least 10 minutes period with or without flush Or Patient being re-implanted with a new pump (first fill with insulin)
- Signed informed consent form prior to enrolment
Who cannot join
- Pump life time > 6 years
- Pump battery voltage < 2.6 volts
- Pregnancy or childbearing potential without a medically approved form of birth control
- 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
17 sites in 4 countries.
17 sites in 4 countries
France12 sites
Investigational Site Number 250-004
Corbeil-Essonnes, 91100
Investigational Site Number 250-008
Dijon, 21000
Investigational Site Number 250-003
Dommartin-lès-Toul, 54200
Investigational Site Number 250-012
Le Mans, 72037
Investigational Site Number 250-009
Lille, 59037
Investigational Site Number 250-007
Marseille, 13385
Investigational Site Number 250-001
Montpellier, 34295
Investigational Site Number 250-005
Paris, 75014
Investigational Site Number 250-010
Pessac, 33604
Investigational Site Number 250-011
Saint-Priest-en-Jarez, 42277
Investigational Site Number 250-002
Strasbourg, 67091
Investigational Site Number 250-006
Toulouse, 31059
Netherlands3 sites
Investigational Site Number 528002
Roermond, 6043CV
Investigational Site Number 528003
The Hague, 2512VA
Investigational Site Number 528001
Zwolle, 8025AB
About this study
Official title: Evaluation of Insuman Implantable 400 IU/ml in Patients With Type 1 Diabetes Treated With the Medtronic MiniMed Implantable Pump System Using Insuplant 400IU/ml
Primary Objective:
To compare Insuman Implantable 400 IU/ml versus Insuplant 400 IU/ml with respect to the pump refill accuracy during a 4 refill cycle period (i.e. the comparative phase); To assess efficacy measured by hemoglobin glycosylated (HBA1c) change in Insuman Implantable 400 IU/ml group versus Insuplant 400 IU/ml group after a 4 refill cycle period (i.e. the comparative phase).
Secondary Objective:
To assess efficacy, safety, refill accuracy evolution and device interventions during the open-label treatment period with Insuman To evaluate daily insulin doses To assess Anti-Insulin Antibodies (ADAs or AIA) levels during all study phases
Read the detailed description
The study duration will be displayed in 2 parts as follow:
Comparative phase (only French patients): 160 +/- 20 days Open label Insuman Implantable extension phase (French and European patients): from day 160 up to the grant of Insuman implantable marketing authorization
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- HUMAN INSULIN (BIOSYNTHETIC), Insuplant
- 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.
HUMAN INSULIN (BIOSYNTHETIC)Drug
Also called HR1799
Pharmaceutical form: solution for infusion Route of administration: Intraperitoneal use Dose regimen: 400 IU/ml
InsuplantDrug
Also called Human insulin semi synthetic porcine derived
Pharmaceutical form:solution for infusion Route of administration: Intraperitoneal use
Dose regimen:
| Study group | Role | What they receive |
|---|---|---|
| Insuman Implantable | Experimental | Starting dose regimen is the same as the one administered to the patient prior randomization, then the insulin odse is established by the investigator on a patient basis in respect to the American Diabetes Association guidelines. Receives: Drug: HUMAN INSULIN (BIOSYNTHETIC) |
| Insuplant | Active comparator | Starting dose regimen is the same as the one administered to the patient prior randomization, then the insulin odse is established by the investigator on a patient basis in respect to the American Diabetes Association guidelines. Receives: Drug: Insuplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refill accuracy between the 2 insulin groups
Measured: During 4 refill cycles
Change in glycosylated hemoglobin (HbA1c)
Measured: From baseline to 6 months
Secondary outcomes (5)
Occurrence of Hypoglycaemia (asymptomatic and symptomatic hypoglycaemia, severe and serious symptomatic hypoglycaemia
Measured: From baseline to 6 months
Occurrence of hyperglycaemia
Measured: From baseline to 6 months
Occurrence of diabetic ketoacidosis
Measured: From baseline to 6 months
Change in insulin dose
Measured: From baseline to 6 months
Antibody assessments (anti-Insulin antibodies)
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study start16 Nov 2010
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 479 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
- NCT01194882
- Sponsor's protocol ID
- HUBIN_L_05335
- Other IDs
- 2010-021373-37, U1111-1116-7658
- Status last verified
- Feb 2018
- First submitted
- 2 Sep 2010
- Last updated
- 15 Feb 2018
- Results posted
- No
Publications
Schaepelynck P, Riveline JP, Renard E, Hanaire H, Guerci B, Baillot-Rudoni S, Sola-Gazagnes A, Catargi B, Fontaine P, Millot L, Martin JF, Tachouaft H, Jeandidier N; EVADIAC Group. Assessment of a new insulin preparation for implanted pumps used in the treatment of type 1 diabetes. Diabetes Technol Ther. 2014 Sep;16(9):582-9. doi: 10.1089/dia.2013.0369. Epub 2014 Apr 15.
PubMed 24735100
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Insuman Implantable 400 IU/ml in Patients With Type 1 Diabetes Treated With the Medtronic MiniMed Implantable Pump System Using Insuplant 400IU/ml
- ClinicalTrials.gov ID
- NCT01194882
- Acronym / sponsor ID
- HUBIN_L_05335
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2010
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 3 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:
To compare Insuman Implantable 400 IU/ml versus Insuplant 400 IU/ml with respect to the pump refill accuracy during a 4 refill cycle period (i.e. the comparative phase); To assess efficacy measured by hemoglobin glycosylated (HBA1c) change in Insuman Implantable 400 IU/ml group versus Insuplant 400 IU/ml group after a 4 refill cycle period (i.e. the comparative phase).
Secondary Objective:
To assess efficacy, safety, refill accuracy evolution and device interventions during the open-label treatment period with Insuman To evaluate daily insulin doses To assess Anti-Insulin Antibodies (ADAs or AIA) levels during all study phases
Detailed description
The study duration will be displayed in 2 parts as follow:
Comparative phase (only French patients): 160 +/- 20 days Open label Insuman Implantable extension phase (French and European patients): from day 160 up to the grant of Insuman implantable marketing authorization
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insuman Implantable | Experimental | Drug: HUMAN INSULIN (BIOSYNTHETIC)Starting dose regimen is the same as the one administered to the patient prior randomization, then the insulin odse is established by the investigator on a patient basis in respect to the American Diabetes Association guidelines. |
| Insuplant | Active comparator | Drug: InsuplantStarting dose regimen is the same as the one administered to the patient prior randomization, then the insulin odse is established by the investigator on a patient basis in respect to the American Diabetes Association guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients already treated with Insuplant 400 IU/ml via a Medtronic Implantable System 2007
- Glycosylated hemoglobin ≤9.0%
- Patient showing a percentage of error at refill equal or below 20%
- Patient undergoing NaOH rinse procedure of at least 10 minutes period with or without flush Or Patient being re-implanted with a new pump (first fill with insulin)
- Signed informed consent form prior to enrolment
Key exclusion criteria (4 listed)
- Pump life time > 6 years
- Pump battery voltage < 2.6 volts
- Pregnancy or childbearing potential without a medically approved form of birth control
- 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 |
|---|---|---|
| HUMAN INSULIN (BIOSYNTHETIC)Also: HR1799Pharmaceutical form: solution for infusion Route of administration: Intraperitoneal use Dose regimen: 400 IU/ml | Drug | Insuman Implantable |
| InsuplantAlso: Human insulin semi synthetic porcine derivedPharmaceutical form:solution for infusion Route of administration: Intraperitoneal use Dose regimen: | Drug | Insuplant |
Primary outcome
Refill accuracy between the 2 insulin groups
Time frame: During 4 refill cycles
Change in glycosylated hemoglobin (HbA1c)
Time frame: From baseline to 6 months
5 secondary outcomes
Occurrence of Hypoglycaemia (asymptomatic and symptomatic hypoglycaemia, severe and serious symptomatic hypoglycaemia
Time frame: From baseline to 6 months
Occurrence of hyperglycaemia
Time frame: From baseline to 6 months
Occurrence of diabetic ketoacidosis
Time frame: From baseline to 6 months
Change in insulin dose
Time frame: From baseline to 6 months
Antibody assessments (anti-Insulin antibodies)
Time frame: From baseline to 6 months
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 Feb 2018.
- Derived from this study: PubMed 24735100Schaepelynck P, Riveline JP, Renard E, Hanaire H, Guerci B, Baillot-Rudoni S, Sola-Gazagnes A, Catargi B, Fontaine P, Millot L, Martin JF, Tachouaft H, Jeandidier N; EVADIAC Group. Assessment of a new insulin preparation for implanted pumps used in the treatment of type 1 diabetes. Diabetes Technol Ther. 2014 Sep;16(9):582-9. doi: 10.1089/dia.2013.0369. Epub 2014 Apr 15.
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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
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HUMAN INSULIN (BIOSYNTHETIC) and Insuplant in people with Diabetes Mellitus, Type 1, run by Sanofi at 17 sites in 4 countries.
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 4 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 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France, Netherlands, Belgium, Sweden. 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?
Refill accuracy between the 2 insulin groups (time frame: During 4 refill cycles). The study lists 2 primary outcomes in all. 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 NCT01194882, 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 15 Feb 2018.