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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2012

Interventions

  • Drug: Insulin glulisine
    • Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
  • Drug: Insulin glargine
    • Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
  • Drug: Premixed insulin (Insulin Aspart 30/70 )
    • Pharmaceutical form:boxes of 5 FlexPens Route of administration: Injection Dose regimen: twice daily

Arms, Groups and Cohorts

  • Experimental: Insulin glargine + Insulin glulisine
    • Daily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal
  • Active Comparator: Premixed insulin
    • twice daily premixed insulin (before breakfast and evening meal).

Clinical Trial Outcome Measures

Primary Measures

  • Glycosylated Haemoglobin (HbA1c) Value
    • Time Frame: 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)
    • Time Frame: at Baseline (week 0), week 2, 12 and 24

Secondary Measures

  • DTSQs (Diabetes Treatment Satisfaction Questionnaire – status)
    • Time Frame: at week 0, 12 and 24
  • DTSQc (Diabetes Treatment Satisfaction Questionnaire – change)
    • Time Frame: at week 24
  • ITSQ (Insulin Treatment Satisfaction Questionnaire)
    • Time Frame: at week 0, 12 and 24
  • Hypoglycemic events
    • Time Frame: at week 0, 2, 12 and 24
  • Adverse Events (excluding hypoglycemic events)
    • Time Frame: at week – 2, 0, 2, 12 and 24

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Sciences & Operations, Study Director, Sanofi

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