Clinical trial NCT01079364: Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-03-03
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Glycosylated Haemoglobin (HbA1c) Value
timeFrame: at screening (week - 2), week 12 (if available) and 24
measure: Self Measured Blood Glucose (SMBG)
timeFrame: at Baseline (week 0), week 2, 12 and 24
Secondary outcomes:
measure: DTSQs (Diabetes Treatment Satisfaction Questionnaire - status)
timeFrame: at week 0, 12 and 24
measure: DTSQc (Diabetes Treatment Satisfaction Questionnaire - change)
timeFrame: at week 24
measure: ITSQ (Insulin Treatment Satisfaction Questionnaire)
timeFrame: at week 0, 12 and 24
measure: Hypoglycemic events
timeFrame: at week 0, 2, 12 and 24
measure: Adverse Events (excluding hypoglycemic events)
timeFrame: at week - 2, 0, 2, 12 and 24
Other outcomes:
Locations:
city: Gouda
country: Netherlands
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: