Long-Acting Insulin Glargine Titration Meter
Research type
Research Study
Full title
A 21-week, open-label, randomized, controlled, parallel-group, multi-center study evaluating the efficacy and safety of HOE901-U300 administered according to a device-supported treat-to-target regimen versus routine titration in T2DM patients
IRAS ID
173243
Contact name
Franklin Joseph
Contact email
Sponsor organisation
Sanofi-Aventis, Recherche & Developpement
Eudract number
2014-004533-13
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
The objective of this study is to compare over 16 weeks the effectiveness, ease of use, and safety of the MyStar DoseCoach meter with standard practice recommendations made by the study doctor to increase and decrease insulin doses and thereby keep blood sugar levels within an acceptable range.
MyStar DoseCoach, is a new blood glucose meter which in addition to measuring blood sugar level, can also recommend increases and decreases of study insulin dose, based upon blood sugar readings and current dose of study insulin.
The study population will consist of patients with type 2 diabetes, who are either initiating insulin glargine HOE901-U300 therapy or switching their established basal insulin to insulin glargine HOE901-U300.HOE901-U300 insulin (the study medication in this study) is a newly developed formulation of Lantus, which has the same active ingredient as Lantus, i.e. insulin glargine. The concentration (the amount of active drug per the same volume of solution for injection) of 300 U insulin glargine/mL implies that the same dose of insulin glargine can be administered with a three times smaller injection volume when given as HOE901-U300 as compared with Lantus.
Approximately 148 patients with type 2 diabetes will participate in the study that will be conducted in approximately 4 countries in Europe. The study will consist of a screening period of 4 weeks and a 16-week treatment period. After the screening period, insulin-naïve patients will be started on insulin glargine HOE901-U300 and patients on established basal insulin will be switched to HOE901-U300. Patients will then be randomized to either titration using the dose recommendation of the MyStar DoseCoach (supervised by the investigator), or the usual method of insulin titration recommended by the investigator. Subsequent visits will occur at weeks 1, 4, and 16. There will be a telephone follow- up one week after the last study visit.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0242
Date of REC Opinion
17 Jul 2015
REC opinion
Further Information Favourable Opinion