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

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01079364
• Other study ID #: APIDR_L_04717
• Secondary ID: 2009-015742-34
• Status: Terminated
• Phase: Phase 4
• First received: February 25, 2010
• Last updated: May 27, 2013
• Start date: January 2010
• Est. completion date: July 2012

Study information

• Verified date: May 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Netherlands	Sanofi-Aventis Administrative Office	Gouda

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at screening (week - 2), week 12 (if available) and 24	No
Primary	Self Measured Blood Glucose (SMBG)		at Baseline (week 0), week 2, 12 and 24	No
Secondary	DTSQs (Diabetes Treatment Satisfaction Questionnaire - status)		at week 0, 12 and 24	No
Secondary	DTSQc (Diabetes Treatment Satisfaction Questionnaire - change)		at week 24	No
Secondary	ITSQ (Insulin Treatment Satisfaction Questionnaire)		at week 0, 12 and 24	No
Secondary	Hypoglycemic events		at week 0, 2, 12 and 24	No
Secondary	Adverse Events (excluding hypoglycemic events)		at week - 2, 0, 2, 12 and 24	No