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

Sanofi

Status and phase: Terminated; Phase 4

Conditions: Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01079364

APIDR_L_04717

2009-015742-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Insulin glargine + Insulin glulisine

Experimental group

Description:

Daily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal

Treatment:

Drug: Insulin glargine

Drug: Insulin glulisine

Premixed insulin

Active Comparator group

Description:

twice daily premixed insulin (before breakfast and evening meal).

Treatment:

Drug: Premixed insulin (Insulin Aspart 30/70 )