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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

NCT02738151

CompletedPhase 4

Sponsor: Sanofi

Conditions: Diabetes Mellitus, Type 2

Interventions: Insulin glargine, 300U/mL, Insulin degludec, 100 U/mL, Non-insulin anti-diabetic treatment

Countries: United States, Bulgaria, Croatia, Czechia, Denmark, France, Greece, Hungary

Primary Objective: To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change from Baseline to Week 24. Secondary Objectives: Change From Baseline in HbA1c to Week 12 To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® at week 12 and week 24 on: * Change in Fasting plasma glucose (FPG); * Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point SMPG profile; * Percentage of participants reaching HbA1c targets \<7% or ≤6.5%; * Percentage of participants reaching HbA1c targets \<7% or ≤6.5% without severe and/or confirmed hypoglycemia * Frequency of occurrence and diurnal distribution of hypoglycemia by American Diabetes Association (ADA) category of hypoglycemia. To assess the safety in each treatment group. To assess the treatment effects in each treatment group on Patient Reported Outcomes (PRO). Percentage of participants requiring rescue therapy.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria :

* 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.

Exclusion criteria:

* 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.

Locations (158)

Sheffield, Alabama, United States
Phoenix, Arizona, United States
Anaheim, California, United States
Chino, California, United States
Huntington Park, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Northridge, California, United States
Palm Springs, California, United States
Santa Ana, California, United States
Torrance, California, United States
Van Nuys, California, United States
Bradenton, Florida, United States
New Port Richey, Florida, United States
Ocoee, Florida, United States
Palm Harbor, Florida, United States
Palm Harbor, Florida, United States
Port Charlotte, Florida, United States
Lawrenceville, Georgia, United States
Roswell, Georgia, United States
Statesboro, Georgia, United States
Stockbridge, Georgia, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Avon, Indiana, United States
Council Bluffs, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
West Des Moines, Iowa, United States
Paris, Kentucky, United States
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