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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Insulin glulisine (Drug); Insulin glargine (Drug); Premixed insulin (Insulin Aspart 30/70 ) (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

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.

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

Primary outcome:

Glycosylated Haemoglobin (HbA1c) Value

Self Measured Blood Glucose (SMBG)

Secondary outcome:

DTSQs (Diabetes Treatment Satisfaction Questionnaire - status)

DTSQc (Diabetes Treatment Satisfaction Questionnaire - change)

ITSQ (Insulin Treatment Satisfaction Questionnaire)

Hypoglycemic events

Adverse Events (excluding hypoglycemic events)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Sanofi-Aventis Administrative Office, Gouda, Netherlands

Starting date: January 2010
Last updated: May 27, 2013