A “Real World” Trial to determine efficacy and health outcomes of TOUJEO compared to “standard of care” basal insulins in insulin naïve patients intiating insulin

• Register: EUCTR
• Last refreshed on: 11 December 2017
• Main ID: EUCTR2015-001831-18-DE
• Date of registration: 11/08/2015
• Prospective Registration: Yes
• Primary sponsor: sanofi-aventis Groupe
• Public title: A “Real World” Trial to determine efficacy and health outcomes of TOUJEO compared to “standard of care” basal insulins in insulin naïve patients intiating insulin
• Scientific title: A twenty six week, randomized, open-label, 2-arm parallel group real world pragmatic trial to assess the clinical and health outcomes benefit of Toujeo® compared to standard of care insulin for initiating basal insulin in insulin naïve patients with uncontrolled type 2 diabetes mellitus, with 6 month extension - Reach - Control
• Date of first enrolment: 05/10/2015
• Target sample size: 680
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001831-18
• 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

Brazil, France, Germany, Greece, Ireland, Italy, Spain, United Kingdom

Contacts

• Affiliation: Sanofi-Aventis Deutschland GmbH

• Affiliation: Sanofi-Aventis Deutschland GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
Patients with type 2 diabetes (T2DM) insufficiently controlled (HbA1c >7%) with current (= 6 months) standard of care with oral agents (metformin, sulfonylurea, thiazolidinedione, dipeptidyl peptidase-4 [DPP-4] inhibitor, sodium-glucose cotransporter 2 [SGLT-2] inhibitor, glinide, Alpha glucosidae inhibitors), and with or without glucagon-like peptide-1 (GLP-1) receptor Agonist, and eligible to basal Insulin Treatment, per investigator's judgement.
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 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 230

Exclusion criteria:
• HbA1c =7%, no upper bound,
• Age <18 years,
• Type 1 diabetes mellitus,
• Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient’s successful participation for the duration of the study,
• Use of any product containing insulin since the time of diagnosis with T2DM other than temporary use during a pregnancy or hospitalization,
• Use of any product containing insulin occurring within 3 months prior to the time of Screening,
• Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP-1 receptor agonists not approved for use with insulin, or any investigational agent (drug, biologic, device) within 3 months prior to the time of screening,
• All contraindications to commercially available insulin therapy or warnings/precautions of use as displayed in the respective National Product labeling for these products,
• Hypersensitivity to insulin glargine or Toujeo excipients,
• Patient is the Investigator or any Sub-investigator, research assistant, pharmacist, studycoordinator, other staff or relative thereof directly involved in the conduct of the protocol,
• Pregnancy or lactation,
• Women of childbearing potential with no effective contraceptive method.


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

Health Condition(s) or Problem(s) studied

Type 2 diabetes mellitus
MedDRA version: 19.1 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-

Pharmaceutical Form: Solution for injection

Primary Outcome(s)

Primary end point(s): Change in HbA1c (expressed in percent)

Main Objective: To demonstrate non-inferiority of Toujeo versus “standard of care” basal insulin therapy measured as glycosylated hemoglobin (HbA1c) change.

Secondary Objective: • To demonstrate superiority of Toujeo versus “standard of care” basal insulin if non-inferiority is met, measured as HbA1c change,
• To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification,
• Risk of hypoglycemia including the incidence of documented symptomatic or severe hypoglycemic events (as defined by the American Diabetes Association Workgroup on Hypoglycemia,
• Change in fasting plasma glucose (FPG),
• Change in body weight,
• Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction
Questionnaire Status and Change Versions (DTSQs and DTSQc),
• Change in hypoglycemia control subscale (HCS),
• Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.

Timepoint(s) of evaluation of this end point: Baseline to 6 months

Secondary Outcome(s)

Secondary end point(s): 1- Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy)
2- Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not
3- Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%,<8.0%)
4- Proportion of patients with HbA1c target (thresholds listed above; attainment of metabolic benefit) without documented (blood glucose [BG] = 70 mg/dl [3.9 mmol/L]) symptomatic or severe hypoglycemia
5- Proportion of patients with HbA1c target (thresholds listed above; attainment of metabolic benefit) without documented (BG <54 mg/dl, [3.0 mmol/L]) symptomatic or severe hypoglycemia
6- Change in HbA1c (expressed in percent)
7- Percentage of patients whose HbA1c decreased at least 1%
8- Percentage of patients whose HbA1c decreased at least 1%
9- Percentage of patients requiring intensification and time to intensification
10- Change in fasting plasma glucose

Timepoint(s) of evaluation of this end point: 1, 2, 3, 4, 5 : at Month 6 and Month 12
6: Baseline to Month 12
7: at Month 6 and Month 12
8: at Month 6 and maintained at Month 12
9: at Month 6 and Month 12
10: Baseline to Month 6 and Month 12

Secondary ID(s)

LPS13931

Source(s) of Monetary Support

sanofi-aventis Groupe