Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist
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 per participant was approximately 27 weeks: an up to 2-week screening period, a 24-week randomized treatment period (including 12 weeks active titration), and a 7-day posttreatment safety follow-up period.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult participants with type 2 diabetes mellitus (T2DM) inadequately controlled with OADs therapy with/without GLP-1 receptor agonist at stable dose for at least 3 months.
Signed written informed consent.
You may not be if
Age \<18 years.
HbA1c \<7.5% or \>10.5% (at screening visit). Body mass index (BMI) \<25 kg/m\^2 or \>40 kg/m\^2.
History of T2DM for less than 1 year before screening.
Less than 6 months before screening on OADs treatment and GLP-1 receptor agonist (if taken).
Current or previous insulin use except for a maximum of 8 consecutive days or totally 15 days (eg, acute illness, surgery) during the last year prior to screening.
Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.
Participant receiving only noninsulin antihyperglycemic drugs not approved for combination with insulin according to local labelling/local treatment guideline.
History of hypoglycemia unawareness or repeated episodes of severe hypoglycemia or metabolic acidosis, including hospitalization for diabetic ketoacidosis during the last 12 months prior to screening.
Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) during the study period.
End stage renal disease.
Any acute or chronic condition that in the opinion of Investigator would affect the safety of participant, compliance, or study results.
Any contraindication to use of Toujeo® or Tresiba® as defined in the national product label, hypersensitivity to Toujeo® or Tresiba® active ingredients or one of the excipients.
Pregnant or breast-feeding women.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Clareo Health | Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist
