Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting (BASAAL PLUS)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Terminated
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Insulin glulisine
Insulin glargine
Premixed insulin (Insulin Aspart 30/70 )
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion criteria:
- 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)
Exclusion criteria:
- 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.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Insulin glargine + Insulin glulisine
Premixed insulin
Arm Description
Daily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal
twice daily premixed insulin (before breakfast and evening meal).
Outcomes
Primary Outcome Measures
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.
Self Measured Blood Glucose (SMBG)
Secondary Outcome Measures
DTSQs (Diabetes Treatment Satisfaction Questionnaire - status)
DTSQc (Diabetes Treatment Satisfaction Questionnaire - change)
ITSQ (Insulin Treatment Satisfaction Questionnaire)
Hypoglycemic events
Adverse Events (excluding hypoglycemic events)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01079364
Brief Title
Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting
Acronym
BASAAL PLUS
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin glargine + Insulin glulisine
Arm Type
Experimental
Arm Description
Daily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal
Arm Title
Premixed insulin
Arm Type
Active Comparator
Arm Description
twice daily premixed insulin (before breakfast and evening meal).
Intervention Type
Drug
Intervention Name(s)
Insulin glulisine
Other Intervention Name(s)
Apidra®
Intervention Description
Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
Intervention Type
Drug
Intervention Name(s)
Insulin glargine
Other Intervention Name(s)
Lantus®
Intervention Description
Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
Intervention Type
Drug
Intervention Name(s)
Premixed insulin (Insulin Aspart 30/70 )
Other Intervention Name(s)
NovoMix 30/70®
Intervention Description
Pharmaceutical form:boxes of 5 FlexPens Route of administration: Injection Dose regimen: twice daily
Primary Outcome Measure Information:
Title
Glycosylated Haemoglobin (HbA1c) Value
Description
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.
Time Frame
at screening (week - 2), week 12 (if available) and 24
Title
Self Measured Blood Glucose (SMBG)
Time Frame
at Baseline (week 0), week 2, 12 and 24
Secondary Outcome Measure Information:
Title
DTSQs (Diabetes Treatment Satisfaction Questionnaire - status)
Time Frame
at week 0, 12 and 24
Title
DTSQc (Diabetes Treatment Satisfaction Questionnaire - change)
Time Frame
at week 24
Title
ITSQ (Insulin Treatment Satisfaction Questionnaire)
Time Frame
at week 0, 12 and 24
Title
Hypoglycemic events
Time Frame
at week 0, 2, 12 and 24
Title
Adverse Events (excluding hypoglycemic events)
Time Frame
at week - 2, 0, 2, 12 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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)
Exclusion criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting
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