Clareo Health | Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications
Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
The study consisted of a 4-week screening period, a 26-week treatment period comparing HOE901-U300 to Lantus, and a 2-day safety follow-up period.
Age
65–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants ≥65 years old with type 2 diabetes mellitus, inadequately controlled on antidiabetic regimens either including no insulin, or with basal insulin as their only insulin.
Signed informed consent.
You may not be if
HbA1c at screening visit:
* \<7.0% or \>10.0% for participants taking basal insulin.
* \<7.5% or \>11.0% for insulin-naïve participants.
History of type 2 diabetes mellitus for less than 1 year before screening.
Participants not on stable basal insulin dose (±10% in the last 8 weeks prior to screening visit).
Change in dose of antidiabetic treatment or initiation of new glucose-lowering medications in the last 8 weeks prior to screening.
Chronic (\>10 days continuous use in previous 6 months) use of bolus insulin injections, whether given separately or as part of a combination with basal insulin, e.g. premix insulin; For insulin-naïve individuals: current or previous insulin use except for a maximum of 10 consecutive days (e.g. acute illness, surgery) during the last year prior to screening.
Cognitive disorder and dementia assessed clinically and by Mini-Mental State Examination (MMSE) score \<24, or any neurologic disorder that would likely affect the participant's ability to follow the study procedure. The participant would be eligible despite an MMSE score \<24 if the investigator determined that the low score reflected educational or cultural background and not dementia as long as the participant was otherwise able to meet the study requirements.
Participants who had end-stage renal disease (\<15 mL/min/1.73m\^2, per estimated Glomerular filtration rate (eGFR) measurement by Modification of Diet in Renal Disease (MDRD).
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
