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

A 24-Week, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of Toujeo® and Tresiba® in Insulin-Naive Patients with Type 2 Diabetes Mellitus Not Adequately Controlled with Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005101-36-DK

Enrollment

1840

Registered

2016-02-09

Start date

2016-05-06

Completion date

Unknown

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus MedDRA version: 18.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Toujeo Product Name: Insulin glargine Product Code: HOE901 - U300 Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: INSULIN GLARGINE CAS Number: 160337-95-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Adult patients 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1380 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 460

Exclusion criteria

Exclusion criteria: -Age 10.5% (at screening visit). -Body mass index (BMI) 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. -Patient 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 patient safety, 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change.;Secondary Objective: -To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® 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 patients reaching HbA1c targets <7% or =6.5%; -Percentage of patients reaching HbA1c targets <7% or =6.5% without severe and/or confirmed hypoglycemia -Percentage of patients requiring rescue therapy. -To assess the 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). ;Primary end point(s): Change from baseline in HbA1c;Timepoint(s) of evaluation of this end point: Baseline to Week 24	—

Measure

Time frame

Main Objective: To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change.;Secondary Objective: -To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® 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 patients reaching HbA1c targets <7% or =6.5%; -Percentage of patients reaching HbA1c targets <7% or =6.5% without severe and/or confirmed hypoglycemia -Percentage of patients requiring rescue therapy. -To assess the 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). ;Primary end point(s): Change from baseline in HbA1c;Timepoint(s) of evaluation of this end point: Baseline to Week 24

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Secondary

Measure	Time frame
Secondary end point(s): 1/ Change from baseline in HbA1c 2/ Change in FPG from Baseline 3/ Change in fasting self-monitoring plasma glucose (SMPG) from baseline 4/ Change in 4-point and 8-point SMPG profiles per time-point from Baseline 5/ Change of mean 24-hour plasma glucose from baseline 6/ Change in variability of fasting SMPG and 24-hour plasma glucose from Baseline 7/ Percentage (%) of patients reaching target HbA1c <7% and =6.5% 8/ Percentage (%) of patients reaching target HbA1c <7% and =6.5% without severe and/or confirmed hypoglycemia 9/ Percentage (%) of patients with sulphonylurea or meglitinide dose reduction due to hypoglycemia 10/ Percentage of patients requiring a rescue therapy 11/ Change in basal insulin dose (U and U/kg body weight) from Baseline 12/ Assessment of hypoglycemia event (ADA category) 13/ Percentage (%) of patients experiencing adverse events 14/ Change in Patient Report Outcomes scores ;Timepoint(s) of evaluation of this end point: 1/ Baseline to Week 12 2-3-4-5-6-7-8-11-14 / Baseline to Week 12 and Week 24 9-10-12-13 / Baseline to Week 24	—

Measure

Time frame

Secondary end point(s): 1/ Change from baseline in HbA1c 2/ Change in FPG from Baseline 3/ Change in fasting self-monitoring plasma glucose (SMPG) from baseline 4/ Change in 4-point and 8-point SMPG profiles per time-point from Baseline 5/ Change of mean 24-hour plasma glucose from baseline 6/ Change in variability of fasting SMPG and 24-hour plasma glucose from Baseline 7/ Percentage (%) of patients reaching target HbA1c <7% and =6.5% 8/ Percentage (%) of patients reaching target HbA1c <7% and =6.5% without severe and/or confirmed hypoglycemia 9/ Percentage (%) of patients with sulphonylurea or meglitinide dose reduction due to hypoglycemia 10/ Percentage of patients requiring a rescue therapy 11/ Change in basal insulin dose (U and U/kg body weight) from Baseline 12/ Assessment of hypoglycemia event (ADA category) 13/ Percentage (%) of patients experiencing adverse events 14/ Change in Patient Report Outcomes scores ;Timepoint(s) of evaluation of this end point: 1/ Baseline to Week 12 2-3-4-5-6-7-8-11-14 / Baseline to Week 12 and Week 24 9-10-12-13 / Baseline to Week 24

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Countries

Bulgaria, Croatia, Czech Republic, Denmark, France, Greece, Hungary, Israel, Italy, Romania, Serbia, Slovakia, Slovenia, Sweden, Switzerland, United Kingdom, United States

Contacts

Public ContactClinical Study Unit

Sanofi Aventis Denmark A/S

clinicaltrialsinfo_denmark@sanofi.com+45 45167000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026