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

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin glulisine; Drug: Insulin glargine; Drug: Premixed insulin (Insulin Aspart 30/70 )

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Gouda, Netherlands
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Insulin glargine + Insulin glulisine; Daily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal	Drug: Insulin glulisine; Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day; Other Names: Apidra®; Drug: Insulin glargine; Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day; Other Names: Lantus®
ACTIVE_COMPARATOR: Premixed insulin; twice daily premixed insulin (before breakfast and evening meal).	Drug: Premixed insulin (Insulin Aspart 30/70 ); Pharmaceutical form:boxes of 5 FlexPens Route of administration: Injection Dose regimen: twice daily; Other Names: NovoMix 30/70®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Self Measured Blood Glucose (SMBG)		at Baseline (week 0), week 2, 12 and 24

Secondary Outcome Measures

Outcome Measure	Time Frame
DTSQs (Diabetes Treatment Satisfaction Questionnaire - status)	at week 0, 12 and 24
DTSQc (Diabetes Treatment Satisfaction Questionnaire - change)	at week 24
ITSQ (Insulin Treatment Satisfaction Questionnaire)	at week 0, 12 and 24
Hypoglycemic events	at week 0, 2, 12 and 24
Adverse Events (excluding hypoglycemic events)	at week - 2, 0, 2, 12 and 24

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: February 25, 2010
• First Submitted That Met QC Criteria: March 2, 2010
• First Posted (ESTIMATE): March 3, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 29, 2013
• Last Update Submitted That Met QC Criteria: May 27, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Glargine; Insulin glulisine; Insulin aspart, insulin aspart protamine drug combination 30:70
• Other Study ID Numbers: APIDR_L_04717; 2009-015742-34 (EUDRACT_NUMBER)