Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGInsulin glulisine
Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
DRUGInsulin glargine
Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
DRUGPremixed insulin (Insulin Aspart 30/70 )
Pharmaceutical form:boxes of 5 FlexPens Route of administration: Injection Dose regimen: twice daily
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycosylated Haemoglobin (HbA1c) Value | at screening (week - 2), week 12 (if available) and 24 | 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) | at Baseline (week 0), week 2, 12 and 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| ITSQ (Insulin Treatment Satisfaction Questionnaire) | at week 0, 12 and 24 |
| DTSQs (Diabetes Treatment Satisfaction Questionnaire - status) | at week 0, 12 and 24 |
| Adverse Events (excluding hypoglycemic events) | at week - 2, 0, 2, 12 and 24 |
| Hypoglycemic events | at week 0, 2, 12 and 24 |
| DTSQc (Diabetes Treatment Satisfaction Questionnaire - change) | at week 24 |
Countries
Netherlands
Outcome results
None listed