Diabetes Mellitus, Type 2Phase 4BASAAL PLUSNCT01079364
Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting
A Phase 4 study testing Insulin glulisine, Insulin glargine and Premixed insulin (Insulin Aspart 30/70 ) in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Netherlands.
Trial summary
Primary Objective: To demonstrate non-inferiority of once daily injection of insulin glargine (Lantus) plus one injection of mealtime insulin glulisine (Apidra) at the main meal versus twice daily premixed insulin (NovoMix 30/70) based on the reduction of HbA1c percentage from baseline to endpoint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin glulisine, Insulin glargine and Premixed insulin (Insulin Aspart 30/70 )
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2010to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes mellitus treated with insulin glargine once daily and oral blood glucose lowering medication
- Patients with a HbA1c > 7%
- Patients with a FBG within range (4-7 mmol/L) at baseline, based on the mean of 3 FBG values (measured 5x during the run-in phase, with the highest and lowest value excluded)
Who cannot join
- Patients treated with an insulin other than insulin glargine
- Patients with hypersensitivity to insulin glargine, insulin glulisine, biphasic insulin aspart/insulin aspart protamine 30/70 or any of the excipients
- Patients with a (pre)proliferative retinopathy (an optic fundus examination should have been performed within the 2 years prior to study entry)
- Pregnant or lactating women
- Patients who are unable to fill in the PRO (Patient Reported Outcomes) questionnaires
- 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: Better Acceptance of a Single Injection Apidra (Insulin Glulisine) Added to Once Daily Lantus (Insulin Glargine) Versus Twice Daily Premixed Insulin in a Real Life Use Setting
Primary Objective:
To demonstrate non-inferiority of once daily injection of insulin glargine (Lantus) plus one injection of mealtime insulin glulisine (Apidra) at the main meal versus twice daily premixed insulin (NovoMix 30/70) based on the reduction of HbA1c percentage from baseline to endpoint.
Read more
Secondary Objective:
- To determine treatment satisfaction (DTSQs/Diabetes Treatment Questionnaire - Status, DTSQc/ Diabetes Treatment Questionnaire - change and ITSQ/Insulin Treatment Satisfaction Questionnaire)
- To determine the mean HbA1c, FBG (Fasting Blood Glucose), prandial BG (Blood Glucose) and proportion of patients with a HbA1c <7%
- To determine the effect on adverse events (e.g. symptomatic hypoglycemic events, weight gain and injection site reactions)
- To determine the total insulin dose, average insulin glargine, insulin glulisine and premixed insulin dosages.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin glulisine, Insulin glargine, Premixed insulin (Insulin Aspart 30/70 )
- 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 glulisineDrug
Also called Apidra®
Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
Insulin glargineDrug
Also called Lantus®
Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
Premixed insulin (Insulin Aspart 30/70 )Drug
Also called NovoMix 30/70®
Pharmaceutical form:boxes of 5 FlexPens Route of administration: Injection Dose regimen: twice daily
| Study group | Role | What they receive |
|---|---|---|
| Insulin glargine + Insulin glulisine | Experimental | Daily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal Receives: Drug: Insulin glulisine; Drug: Insulin glargine |
| Premixed insulin | Active comparator | twice daily premixed insulin (before breakfast and evening meal). Receives: Drug: Premixed insulin (Insulin Aspart 30/70 ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated Haemoglobin (HbA1c) Value
Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients.
Measured: at screening (week - 2), week 12 (if available) and 24
Self Measured Blood Glucose (SMBG)
Measured: at Baseline (week 0), week 2, 12 and 24
Secondary outcomes (5)
DTSQs (Diabetes Treatment Satisfaction Questionnaire - status)
Measured: at week 0, 12 and 24
DTSQc (Diabetes Treatment Satisfaction Questionnaire - change)
Measured: at week 24
ITSQ (Insulin Treatment Satisfaction Questionnaire)
Measured: at week 0, 12 and 24
Hypoglycemic events
Measured: at week 0, 2, 12 and 24
Adverse Events (excluding hypoglycemic events)
Measured: at week - 2, 0, 2, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Slow recruitment
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
- 52 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
- NCT01079364
- Sponsor's protocol ID
- APIDR_L_04717
- Other IDs
- 2009-015742-34, 2009
- Acronym
- BASAAL PLUS
- Status last verified
- May 2013
- First submitted
- 25 Feb 2010
- Last updated
- 29 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Acceptance of a Single Injection Apidra (Insulin Glulisine) Added to Once Daily Lantus (Insulin Glargine) Versus Twice Daily Premixed Insulin in a Real Life Use Setting
- ClinicalTrials.gov ID
- NCT01079364
- Acronym / sponsor ID
- BASAAL PLUS / APIDR_L_04717
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 52 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 3 Mar 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 demonstrate non-inferiority of once daily injection of insulin glargine (Lantus) plus one injection of mealtime insulin glulisine (Apidra) at the main meal versus twice daily premixed insulin (NovoMix 30/70) based on the reduction of HbA1c percentage from baseline to endpoint.
Secondary Objective:
- To determine treatment satisfaction (DTSQs/Diabetes Treatment Questionnaire - Status, DTSQc/ Diabetes Treatment Questionnaire - change and ITSQ/Insulin Treatment Satisfaction Questionnaire)
- To determine the mean HbA1c, FBG (Fasting Blood Glucose), prandial BG (Blood Glucose) and proportion of patients with a HbA1c <7%
- To determine the effect on adverse events (e.g. symptomatic hypoglycemic events, weight gain and injection site reactions)
- To determine the total insulin dose, average insulin glargine, insulin glulisine and premixed insulin dosages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin glargine + Insulin glulisine | Experimental | Drug: Insulin glulisine, Drug: Insulin glargineDaily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal |
| Premixed insulin | Active comparator | Drug: Premixed insulin (Insulin Aspart 30/70 )twice daily premixed insulin (before breakfast and evening meal). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with type 2 diabetes mellitus treated with insulin glargine once daily and oral blood glucose lowering medication
- Patients with a HbA1c > 7%
- Patients with a FBG within range (4-7 mmol/L) at baseline, based on the mean of 3 FBG values (measured 5x during the run-in phase, with the highest and lowest value excluded)
Key exclusion criteria (6 listed)
- Patients treated with an insulin other than insulin glargine
- Patients with hypersensitivity to insulin glargine, insulin glulisine, biphasic insulin aspart/insulin aspart protamine 30/70 or any of the excipients
- Patients with a (pre)proliferative retinopathy (an optic fundus examination should have been performed within the 2 years prior to study entry)
- Pregnant or lactating women
- Patients who are unable to fill in the PRO (Patient Reported Outcomes) questionnaires
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: Apidra®Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day | Drug | Insulin glargine + Insulin glulisine |
| Insulin glargineAlso: Lantus®Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day | Drug | Insulin glargine + Insulin glulisine |
| Premixed insulin (Insulin Aspart 30/70 )Also: NovoMix 30/70®Pharmaceutical form:boxes of 5 FlexPens Route of administration: Injection Dose regimen: twice daily | Drug | Premixed insulin |
Primary outcome
Glycosylated Haemoglobin (HbA1c) Value
Time frame: at screening (week - 2), week 12 (if available) and 24
Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients.
Self Measured Blood Glucose (SMBG)
Time frame: at Baseline (week 0), week 2, 12 and 24
5 secondary outcomes
DTSQs (Diabetes Treatment Satisfaction Questionnaire - status)
Time frame: at week 0, 12 and 24
DTSQc (Diabetes Treatment Satisfaction Questionnaire - change)
Time frame: at week 24
ITSQ (Insulin Treatment Satisfaction Questionnaire)
Time frame: at week 0, 12 and 24
Hypoglycemic events
Time frame: at week 0, 2, 12 and 24
Adverse Events (excluding hypoglycemic events)
Time frame: at week - 2, 0, 2, 12 and 24
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
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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, Insulin glargine and Premixed insulin (Insulin Aspart 30/70 ) in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Netherlands.
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 6 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: stopped early, as of the sponsor's last update on 29 May 2013. 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 Netherlands. 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 was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
Glycosylated Haemoglobin (HbA1c) Value (time frame: at screening (week - 2), week 12 (if available) and 24). 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?
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 29 May 2013.