To demonstrate non-inferiority of Toujeo versus *standard of care* basal insulin therapy asmeasured by HbA1c change from baseline to Month 6.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To demonstrate non-inferiority of Toujeo versus *standard of care* basal
insulin therapy as measured by glycated hemoglobin (HbA1c) change.
Secondary outcome
-To demonstrate superiority of Toujeo versus *standard of care* basal insulin
if non-inferiority criterion is met, measured by 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 documented, symptomatic hypoglycemia (*70
mg/dL) or severe (according to ADA Working Group).
-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 hypoglycemic control subscale (HCS).
-Healthcare resource utilization including hospitalizations and emergency
department or other healthcare provider visits and healthcare costs.
Background summary
The profile of Toujeo compared to Lantus and other *standard of care* basal
insulins, combined with a new pen device and an appropriate individualized
support, should allow target HbA1c achievement with a lower risk of
hypoglycemia. This, in turn, should result in greater patient satisfaction with
treatment. A greater number of patients at glycemic goal without hypoglycemia
should also lead to decreased resource utilization and associated healthcare
costs.
This combination of improved clinical outcomes accompanied by greater patient
satisfaction and decreased healthcare costs is of considerable interest to
payers globally
Study objective
To demonstrate non-inferiority of Toujeo versus *standard of care* basal
insulin therapy as
measured by HbA1c change from baseline to Month 6.
Study design
A phase 4, randomized, open-label, 2-arm parallel group trial.
Intervention
There are two groups:
Group 1: Toujeo 1 time a day by subcutaneous injection.
Group 2: standard of care insulin, 1 or 2 twice a day in the morning and
optional in the evening by subcutanious injection.
Study burden and risks
Patients with a poor glycemic control are better followed independent of the
type of insulin they use. Because of this a better glycemic control is expected
with in return a lowering of hospitalization or health care utilization.
Patients are expected to come to the hospital for 6 visits in total, which
creates also a better awareness for their disease.
Kampenringweg 45 E
Gouda 2803PE
NL
Kampenringweg 45 E
Gouda 2803PE
NL
Listed location countries
Age
Inclusion criteria
* Patients with type 2 diabetes insufficiently controlled (HbA1c >7%) with current (* 6 months) *standard of care* basal insulin therapy (including insulin glargine U100, Levemir, NPH or Tresiba) with or without oral agents (metformin, sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinides, alpha glucosidase inhibitors) and with or without use of a GLP-1 receptor agonist, ;* Fasting plasma glucose (FPG) >130 mg/dL (7.2 mmol/L), ;* Adult patients who have signed an Informed Consent Form (ICF) and privacy form(s).
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 short or rapid acting insulin since the time of diagnosis with type 2 diabetes mellitus other than temporary use during a pregnancy or hospitalization,
* Use of any product containing short or rapid acting 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 *standard of care* 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
* Pregnancy or lactation,
* Women of childbearing potential with no effective contraceptive method.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-001832-39-NL |
| CCMO | NL56445.028.16 |