A twenty-six week, randomized, open-label, 2-arm parallel group real world pragmatic trial to assess the clinical and health outcomes benefit of transition to Toujeo compared to standard of care insulin, in basal insulin treated patients with uncontrolled type 2 diabetes mellitus, with six month extension.
- Conditions
- Diabetes Mellitus type 210018424
- Registration Number
- NL-OMON43525
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 20
* 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).
* 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To demonstrate non-inferiority of Toujeo versus *standard of care* basal<br /><br>insulin therapy as measured by glycated hemoglobin (HbA1c) change.</p><br>
- Secondary Outcome Measures
Name Time Method <p>-To demonstrate superiority of Toujeo versus *standard of care* basal insulin<br /><br>if non-inferiority criterion is met, measured by HbA1c change.<br /><br>-To compare Toujeo to other standard of care basal insulin in terms of<br /><br>patient persistence with assigned basal insulin therapy with or without<br /><br>intensification<br /><br>-Risk of hypoglycemia including documented, symptomatic hypoglycemia (*70<br /><br>mg/dL) or severe (according to ADA Working Group).<br /><br>-Change in fasting plasma glucose (FPG).<br /><br>-Change in body weight.<br /><br>-Differences in patient reported outcomes measured by Diabetes Treatment<br /><br>Satisfaction Questionnaire Status and Change versions (DTSQs and DTSQc).<br /><br>-Change in hypoglycemic control subscale (HCS).<br /><br>-Healthcare resource utilization including hospitalizations and emergency<br /><br>department or other healthcare provider visits and healthcare costs.</p><br>