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

Phase 4

Terminated

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin glulisine; Drug: Premixed insulin (Insulin Aspart 30/70 ); Drug: Insulin glargine

• Registration Number: NCT01079364
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-27
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin glargine + Insulin glulisine	Insulin glulisine	Daily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal
Premixed insulin	Premixed insulin (Insulin Aspart 30/70 )	twice daily premixed insulin (before breakfast and evening meal).
Insulin glargine + Insulin glulisine	Insulin glargine	Daily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
DTSQs (Diabetes Treatment Satisfaction Questionnaire - status)	at week 0, 12 and 24
DTSQc (Diabetes Treatment Satisfaction Questionnaire - change)	at week 24
ITSQ (Insulin Treatment Satisfaction Questionnaire)	at week 0, 12 and 24
Hypoglycemic events	at week 0, 2, 12 and 24
Adverse Events (excluding hypoglycemic events)	at week - 2, 0, 2, 12 and 24

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇳🇱 Gouda, Netherlands