Diabetes Mellitus, Type 1Phase 4PORTAL 1NCT00964574
Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus
A Phase 4 study testing INSULIN GLULISINE (HMR1964) and INSULIN GLARGINE in people with Diabetes Mellitus, Type 1, run by Sanofi at 1 site in Belarus.
Trial summary
Primary Objective: To evaluate the efficacy and the safety of insulin glulisine in type I Diabetes Melittus (DM) patients Secondary Objective: To evaluate the insulin glulisine doses To assess the patient satisfaction 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 (HMR1964) and INSULIN GLARGINE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBelarus
- Study dates
- Jul 2009to Jul 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen
- 6.5 <=HbA1c <= 11% at visit 1
- BMI <35 kg/m²
- Provision of signed and dated informed consent prior to any study procedures
- Ability and willingness to complete study diaries and questionnaires
- Demonstrated ability to use the self-glucose-monitoring device, and to self-inject insulin
- A negative pregnancy test for all females of childbearing potential.
Who cannot join
- Hypersensitivity to insulin Glulisine, insulin Glargine or one of their excipients
- Pregnant women
- Active proliferative diabetic retinopathy
- 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: Multicentre, Open, Non-randomised Controlled Phase IV Clinical Trial of Efficacy and Safety for Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine
Primary Objective:
To evaluate the efficacy and the safety of insulin glulisine in type I Diabetes Melittus (DM) patients
Secondary Objective:
To evaluate the insulin glulisine doses To assess the patient satisfaction
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- INSULIN GLULISINE (HMR1964), 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 GLULISINE (HMR1964)Drug
Pharmaceutical form:
APIDRA 100U/ml flacon for the titration period in the hospital APIDRA 100U/ml solution for injection in cartridge in OptiSet
Route of administration:
3-4 subcutaneous injections per day
INSULIN GLARGINEDrug
Pharmaceutical form:
LANTUS 100U/ml solution for injection in cartridge
Route of administration:
Once daily subcutaneous injection in the evening
| Study group | Role | What they receive |
|---|---|---|
| APIDRA + LANTUS basal | Experimental | The 2 first weeks, patients will receive subcutaneous injection of Insulin Glulisine and Insulin Glargine once daily in hospital. The rest of the treatement is to be take at home until week 12 Receives: Drug: INSULIN GLULISINE (HMR1964); Drug: INSULIN GLARGINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Glycosylated haemoglobin (HbA1c)
Measured: Week 12
Secondary outcomes (5)
Mean Glycosylated haemoglobin (HbA1c)
Measured: Week 12
Mean Fasting Blood Glucose and mean Post Prandial Glycemia
Measured: Week 12
Number of documented symptomatic hypoglycaemic episodes
Measured: From week 0 to week 12
Mean dose and mean dose change of insulin glulisine, basal glulisine and total insulin from baseline
Measured: week 12
Mean change of Fasting Blood Glucose and Post Prandial Glycemia
Measured: From week 0 to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionJul 2010
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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natallia Zhyhaila, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964574
- Sponsor's protocol ID
- APIDR_L_02483
- Acronym
- PORTAL 1
- Status last verified
- Jul 2012
- First submitted
- 24 Aug 2009
- Last updated
- 17 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Open, Non-randomised Controlled Phase IV Clinical Trial of Efficacy and Safety for Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine
- ClinicalTrials.gov ID
- NCT00964574
- Acronym / sponsor ID
- PORTAL 1 / APIDR_L_02483
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 25 Aug 2009 (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 evaluate the efficacy and the safety of insulin glulisine in type I Diabetes Melittus (DM) patients
Secondary Objective:
To evaluate the insulin glulisine doses To assess the patient satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APIDRA + LANTUS basal | Experimental | Drug: INSULIN GLULISINE (HMR1964), Drug: INSULIN GLARGINEThe 2 first weeks, patients will receive subcutaneous injection of Insulin Glulisine and Insulin Glargine once daily in hospital. The rest of the treatement is to be take at home until week 12 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen
- 6.5 <=HbA1c <= 11% at visit 1
- BMI <35 kg/m²
- Provision of signed and dated informed consent prior to any study procedures
- Ability and willingness to complete study diaries and questionnaires
Key exclusion criteria (5 listed)
- Hypersensitivity to insulin Glulisine, insulin Glargine or one of their excipients
- Pregnant women
- Active proliferative diabetic retinopathy
- 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.
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 (HMR1964)Pharmaceutical form: APIDRA 100U/ml flacon for the titration period in the hospital APIDRA 100U/ml solution for injection in cartridge in OptiSet Route of administration: 3-4 subcutaneous injections per day | Drug | APIDRA + LANTUS basal |
| INSULIN GLARGINEPharmaceutical form: LANTUS 100U/ml solution for injection in cartridge Route of administration: Once daily subcutaneous injection in the evening | Drug | APIDRA + LANTUS basal |
Primary outcome
Mean change in Glycosylated haemoglobin (HbA1c)
Time frame: Week 12
5 secondary outcomes
Mean Glycosylated haemoglobin (HbA1c)
Time frame: Week 12
Mean Fasting Blood Glucose and mean Post Prandial Glycemia
Time frame: Week 12
Number of documented symptomatic hypoglycaemic episodes
Time frame: From week 0 to week 12
Mean dose and mean dose change of insulin glulisine, basal glulisine and total insulin from baseline
Time frame: week 12
Mean change of Fasting Blood Glucose and Post Prandial Glycemia
Time frame: From week 0 to week 12
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 17 Jul 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.
Natallia Zhyhaila 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 (HMR1964) and INSULIN GLARGINE in people with Diabetes Mellitus, Type 1, run by Sanofi at 1 site in Belarus.
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 7 inclusion and 5 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 17 Jul 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 Belarus. 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?
Mean change in Glycosylated haemoglobin (HbA1c) (time frame: Week 12). 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 17 Jul 2012.