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

• Register: EUCTR
• Last refreshed on: 27 August 2018
• Main ID: EUCTR2015-005101-36-CZ
• Date of registration: 08/03/2016
• Prospective Registration: Yes
• Primary sponsor: sanofi-aventis Groupe
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 08/04/2016
• Target sample size: 1840
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005101-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

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

Contacts

• Name: www.sanofi.cz
• Affiliation: sanofi-aventis, s.r.o.

• Name: www.sanofi.cz
• Affiliation: sanofi-aventis, s.r.o.

Key inclusion & exclusion 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:
-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.
-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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 diabetes mellitus
MedDRA version: 19.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

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: 160337-95-1
Current Sponsor code: HOE901 - U300
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 300-

Trade Name: Tresiba
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: INSULIN DEGLUDEC
CAS Number: 844439-96-9
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

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).

Main Objective: To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change.

Primary end point(s): Change from baseline in HbA1c

Timepoint(s) of evaluation of this end point: Baseline to Week 24

Secondary Outcome(s)

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

Secondary ID(s)

LPS14584

2015-005101-36-DK

Source(s) of Monetary Support

sanofi-aventis Groupe