BASAAL PLUSSingle Injection of Apidra and Lantus vs Twice Daily Premixed Insulin for Diabetes Treatment Satisfaction and HbA1c Reduction
This study aims to compare the satisfaction and reduction in HbA1c levels in diabetes patients treated with either a single injection of Apidra and Lantus or twice daily premixed insulin.
Insulin glulisine
+ Insulin glargine
+ Premixed insulin (Insulin Aspart 30/70 )
Diabetes Mellitus+3
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: January 1, 2010
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.52 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Sanofi-Aventis Administrative Office
Gouda, NetherlandsOpen Sanofi-Aventis Administrative Office in Google Maps