Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
- To compare the efficacy of a new formulation of insulin glargine and Lantus (overall,
regardless the injection time) in terms of change of HbA1c from baseline to endpoint
(scheduled Month 6) in participants with type 1 diabetes mellitus
Secondary Objective:
- To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms
of:
- Change of HbA1c from baseline to endpoint (scheduled Month 6)
- Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma
glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma
glucose (8-point profiles), glucose variability, treatment satisfaction and health
related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)
- Reaching target HbA1c values and controlled plasma glucose (all and reaching target
without hypoglycemia)
- Frequency of occurrence and diurnal distribution of hypoglycemia by category of
hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)
- Safety and tolerability of HOE901-U300 including development of anti-insulin antibody
(AIAs) during the 12-month study period