Clareo Health | Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
The maximum study duration was up to approximately 58 weeks per participants, consisting of:
* up to 2 week screening period
* 6-month comparative efficacy and safety treatment period
* 6-month comparative safety extension period
* 4-week safety follow-up period in a subset of participants
* a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to HOE901-U300
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants with type 2 diabetes mellitus
* Completion of the 6-month study period in main study (Visit 10)
* Randomized and treated with insulin glargine new formulation during the 6- month treatment period (Baseline - Month 6)
You may not be if
Age less than (\<) 18 years
HbA1c \<7.0% or greater than (\>) 10% at screening
Diabetes other than type 2 diabetes mellitus
Less than 6 months on basal insulin treatment together with oral antihyperglycemic drug(s) and self-monitoring of blood glucose
Participants using sulfonylurea in the last 2 months before screening visit
Any contraindication to use of insulin glargine as defined in the national product label
Use of insulin pump in the last 6 months before screening
Initiation of new glucose-lowering medications in the last 3 months before screening visit
History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period
Pregnant or breast-feeding women or women who intend to become pregnant during the study period
* Participant not willing to use the adaptable injection intervals on at least two days per week
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
