Diabetes Mellitus, Type 2Phase 4SeLanNCT01234597
Evaluation of the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 Diabetes Mellitus (DM) Patients Uncontrolled With a Basal Insulin or Premix Once a Day
A Phase 4 study testing INSULIN GLARGINE (HOE901) and INSULIN GLULISINE (HMR1964) in people with Diabetes Mellitus, Type 2, run by Sanofi at 11 sites in Israel.
Trial summary
Primary Objective: To evaluate the effect of prandial treatment adjustment, based on continuous blood glucose monitoring, on glucose control in type 2 diabetes patients who are not controlled by treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus regimen Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- INSULIN GLARGINE (HOE901) and INSULIN GLULISINE (HMR1964)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 11 sitesIsrael
- Study dates
- Dec 2012to Apr 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Run-in period:
- Type 2 diabetes
- HbA1c≥ 8.5% (in a test of the last month)
- Age above 21 years
- Patients continuously treated with basal insulin or mixed insulin once daily for the last 6 months
- Signed informed consent form
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- Patients who according to their physician are eligible to the study
- Randomization:
- HbA1c > 7.5%
- FPG < 130 mg/dl
Who cannot join
- Type 1 diabetes
- Patients continuously treated with short-acting insulin or mixed insulin more than once daily for 3 weeks during the last 6 months.
- Pregnant or breastfeeding women.
- Patients with allergy to insulin.
- Patients with severe diseases characterized by recurrent hospitalizations, including: Severe renal insufficiency, severe cardiac insufficiency, active oncological disease or oncological disease requiring chemotherapy.
- Patients with mobility difficulties and/or difficulties communicating with the investigator
- 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
11 sites in 1 country.
11 sites in 1 country
Israel11 sites
Investigational Site Number 376003
Beersheba
Investigational Site Number 376007
Haifa
Investigational Site Number 376004
Kfar Saba, 44281
Investigational Site Number 376012
Lod
Investigational Site Number 376013
Nazareth
Investigational Site Number 376006
Netanya
Investigational Site Number 376001
Ramat Gan
Investigational Site Number 376009
Sakhnin
Investigational Site Number 376008
Tel Aviv
Investigational Site Number 376010
Tel Aviv
Investigational Site Number 376011
Tel Aviv
About this study
Official title: A Comparative Study to Evaluate the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 DM Patients Uncontrolled With a Basal Insulin or Premix Once a Day
Primary Objective:
To evaluate the effect of prandial treatment adjustment, based on continuous blood glucose monitoring, on glucose control in type 2 diabetes patients who are not controlled by treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus regimen
Read the detailed description
The study duration for each patient is 24 weeks +/- 1 week broken down as follows:
- Run-in phase: 8 weeks
- Follow - up Period: 16 weeks
The maximal possible time window during the study is +/- one week throughout the study.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- INSULIN GLARGINE (HOE901), INSULIN GLULISINE (HMR1964)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSULIN GLARGINE (HOE901)Drug
Pharmaceutical form: solution for injection Route of administration: subcutaneous
INSULIN GLULISINE (HMR1964)Drug
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Without Continous Glucose Monitoring (CGM) sensor | Active comparator | Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer .
Treatment phase: insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the treating physician Receives: Drug: INSULIN GLARGINE (HOE901); Drug: INSULIN GLULISINE (HMR1964) |
| Arm B: Continous Glucose Monitoring (CGM) sensor | Experimental | Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer .
Treatment phase: the patients are connected to a CGM sensor. Insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the national coordinator based on the data collected in the past previous days of CGM sensor monitoring. Receives: Drug: INSULIN GLARGINE (HOE901); Drug: INSULIN GLULISINE (HMR1964) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Hemoglobin A1c (HbA1c) level
Measured: Baseline, week 24
Secondary outcomes (3)
Rate of hypoglycemia
Measured: Week 24
Changes in insulin glargine dose
Measured: Baseline, week 24
Changes in insulin glulisine dose
Measured: Baseline, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startDec 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 219 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
- NCT01234597
- Sponsor's protocol ID
- LANTU_L_05146
- Other IDs
- U1111-1116-2926
- Acronym
- SeLan
- Status last verified
- Jul 2016
- First submitted
- 3 Nov 2010
- Last updated
- 13 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study to Evaluate the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 DM Patients Uncontrolled With a Basal Insulin or Premix Once a Day
- ClinicalTrials.gov ID
- NCT01234597
- Acronym / sponsor ID
- SeLan / LANTU_L_05146
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 4 Nov 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 evaluate the effect of prandial treatment adjustment, based on continuous blood glucose monitoring, on glucose control in type 2 diabetes patients who are not controlled by treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus regimen
Detailed description
The study duration for each patient is 24 weeks +/- 1 week broken down as follows:
- Run-in phase: 8 weeks
- Follow - up Period: 16 weeks
The maximal possible time window during the study is +/- one week throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Without Continous Glucose Monitoring (CGM) sensor | Active comparator | Drug: INSULIN GLARGINE (HOE901), Drug: INSULIN GLULISINE (HMR1964)Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the treating physician |
| Arm B: Continous Glucose Monitoring (CGM) sensor | Experimental | Drug: INSULIN GLARGINE (HOE901), Drug: INSULIN GLULISINE (HMR1964)Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: the patients are connected to a CGM sensor. Insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the national coordinator based on the data collected in the past previous days of CGM sensor monitoring. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Type 2 diabetes
- HbA1c≥ 8.5% (in a test of the last month)
- Age above 21 years
- Patients continuously treated with basal insulin or mixed insulin once daily for the last 6 months
- Signed informed consent form
Key exclusion criteria (7 listed)
- Type 1 diabetes
- Patients continuously treated with short-acting insulin or mixed insulin more than once daily for 3 weeks during the last 6 months.
- Pregnant or breastfeeding women.
- Patients with allergy to insulin.
- Patients with severe diseases characterized by recurrent hospitalizations, including: Severe renal insufficiency, severe cardiac insufficiency, active oncological disease or oncological disease requiring chemotherapy.
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 GLARGINE (HOE901)Pharmaceutical form: solution for injection Route of administration: subcutaneous | Drug | Arm A: Without Continous Glucose Monitoring (CGM) sensor, Arm B: Continous Glucose Monitoring (CGM) sensor |
| INSULIN GLULISINE (HMR1964)Pharmaceutical form:Solution for injection Route of administration: Subcutaneous | Drug | Arm A: Without Continous Glucose Monitoring (CGM) sensor, Arm B: Continous Glucose Monitoring (CGM) sensor |
Primary outcome
Changes in Hemoglobin A1c (HbA1c) level
Time frame: Baseline, week 24
3 secondary outcomes
Rate of hypoglycemia
Time frame: Week 24
Changes in insulin glargine dose
Time frame: Baseline, week 24
Changes in insulin glulisine dose
Time frame: Baseline, week 24
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 13 Jul 2016.
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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
11 sites 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 GLARGINE (HOE901) and INSULIN GLULISINE (HMR1964) in people with Diabetes Mellitus, Type 2, run by Sanofi at 11 sites in Israel.
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 10 inclusion and 7 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 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Israel. 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?
Changes in Hemoglobin A1c (HbA1c) level (time frame: Baseline, week 24). 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 13 Jul 2016.