Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting
NCT ID: NCT01079364
Last Updated: 2013-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
52 participants
INTERVENTIONAL
2010-01-31
2012-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Insulin glargine + Insulin glulisine
Daily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal
Insulin glulisine
Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
Insulin glargine
Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
Premixed insulin
twice daily premixed insulin (before breakfast and evening meal).
Premixed insulin (Insulin Aspart 30/70 )
Pharmaceutical form:boxes of 5 FlexPens Route of administration: Injection Dose regimen: twice daily
Interventions
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Insulin glulisine
Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
Insulin glargine
Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
Premixed insulin (Insulin Aspart 30/70 )
Pharmaceutical form:boxes of 5 FlexPens Route of administration: Injection Dose regimen: twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Gouda, , Netherlands
Countries
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Other Identifiers
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2009-015742-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
APIDR_L_04717
Identifier Type: -
Identifier Source: org_study_id
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