Study S002678

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 Patients With Type 2 Diabetes Mellitus

ClinicalTrials.gov record

Registration

Registration: NCT02585674
Acronym: AUTOMATIX
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 151
Start: 2015-12
Primary completion: 2016-11
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Insulin glargine (U300); DEVICE:MyStar DoseCoach
Results posted: FALSE
Secondary identifiers: EUDRACT_NUMBER:2014-004533-13; OTHER:U1111-1165-9001; NIH:2014

Registered primary outcomes

Percentage of patients reaching fasting SMPG target range 90-130 mg/dL (5.0-7.2 mmol/L) at Week 16 (mean of the last 5 readings recorded over the last 2 weeks) without a severe hypoglycemic episode during the 16-week on-treatment period [Baseline to Week 16]

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