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Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting (BASAAL PLUS)

This study has been terminated.
(Slow recruitment)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01079364
First received: February 25, 2010
Last updated: May 27, 2013
Last verified: May 2013

February 25, 2010
May 27, 2013
January 2010
July 2012   (final data collection date for primary outcome measure)
  • Glycosylated Haemoglobin (HbA1c) Value [ Time Frame: at screening (week - 2), week 12 (if available) and 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Glycosylated Haemoglobin (HbA1c) Value [ Time Frame: at screening (week - 2), week 12 (if available) and 24 ] [ Designated as safety issue: No ]
    Glycolysated 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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01079364 on ClinicalTrials.gov Archive Site
  • DTSQs (Diabetes Treatment Satisfaction Questionnaire - status) [ Time Frame: at week 0, 12 and 24 ] [ Designated as safety issue: No ]
  • DTSQc (Diabetes Treatment Satisfaction Questionnaire - change) [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • ITSQ (Insulin Treatment Satisfaction Questionnaire) [ Time Frame: at week 0, 12 and 24 ] [ Designated as safety issue: No ]
  • Hypoglycemic events [ Time Frame: at week 0, 2, 12 and 24 ] [ Designated as safety issue: No ]
  • Adverse Events (excluding hypoglycemic events) [ Time Frame: at week - 2, 0, 2, 12 and 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting
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.

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Insulin glulisine
    Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
    Other Name: Apidra®
  • Drug: Insulin glargine
    Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
    Other Name: Lantus®
  • Drug: Premixed insulin (Insulin Aspart 30/70 )
    Pharmaceutical form:boxes of 5 FlexPens Route of administration: Injection Dose regimen: twice daily
    Other Name: NovoMix 30/70®
  • Experimental: Insulin glargine + Insulin glulisine
    Daily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal
    Interventions:
    • Drug: Insulin glulisine
    • Drug: Insulin glargine
  • Active Comparator: Premixed insulin
    twice daily premixed insulin (before breakfast and evening meal).
    Intervention: Drug: Premixed insulin (Insulin Aspart 30/70 )
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
52
July 2012
July 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01079364
APIDR_L_04717, 2009-015742-34
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP