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

NCT01079364 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2013-05-29

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01079364 on ClinicalTrials.gov