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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 25, 2010

Last Updated Date

May 27, 2013

Start Date ^ICMJE

January 2010

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT01079364 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

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®

Study Arm (s)

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 )

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2012

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01079364

Other Study ID Numbers ^ICMJE

APIDR_L_04717, 2009-015742-34

Has Data Monitoring Committee

Not Provided

Responsible Party

Sanofi

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Sciences & Operations

Sanofi

Information Provided By

Sanofi

Verification Date

May 2013

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

To Top