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

Completed · Phase 4

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT02738151

Run by

Sanofi

People needed

929

Starts

2016-05-19

Expected to finish

2017-08-15

Last updated by the study team

2018-09-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• Investigational Site Number 840066 — Phoenix, Arizona, United States
• Investigational Site Number 840051 — Anaheim, California, United States
• Investigational Site Number 840081 — Chino, California, United States
• Investigational Site Number 840016 — Huntington Park, California, United States
• Investigational Site Number 840002 — La Jolla, California, United States
• Investigational Site Number 840091 — Los Angeles, California, United States
• Investigational Site Number 840058 — Northridge, California, United States
• Investigational Site Number 840021 — Palm Springs, California, United States
• Investigational Site Number 840087 — Santa Ana, California, United States
• Investigational Site Number 840030 — Torrance, California, United States
• Investigational Site Number 840065 — Van Nuys, California, United States
• Investigational Site Number 840075 — Bradenton, Florida, United States
• Investigational Site Number 840076 — New Port Richey, Florida, United States
• Investigational Site Number 840026 — Ocoee, Florida, United States
• Investigational Site Number 840052 — Palm Harbor, Florida, United States
• Investigational Site Number 840080 — Palm Harbor, Florida, United States
• Investigational Site Number 840018 — Port Charlotte, Florida, United States
• Investigational Site Number 840071 — Lawrenceville, Georgia, United States
• Investigational Site Number 840085 — Roswell, Georgia, United States
• Investigational Site Number 840072 — Statesboro, Georgia, United States
• Investigational Site Number 840039 — Stockbridge, Georgia, United States
• Investigational Site Number 840036 — Arlington Heights, Illinois, United States
• Investigational Site Number 840010 — Chicago, Illinois, United States
• Investigational Site Number 840005 — Avon, Indiana, United States
• Investigational Site Number 840038 — Sheffield, Alabama, United States

Full record on ClinicalTrials.gov

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