A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulin in Patients Already Using Basal Insulin (REGAIN CONTROL)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: insulin glargine (U300); Drug: insulin detemir; Drug: NPH insulin; Drug: insulin glargine (U100); Drug: insulin degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT02967211

LPS14060

2015-001832-39 (EudraCT Number)

U1111-1170-8132 (Other Identifier)

Details and patient eligibility

About

Primary Objective:

To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy as measured by glycated hemoglobin (HbA1c) change

Secondary Objectives:

• 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 health care provider visits and healthcare costs.

Full description

The total study duration will be up to 55 weeks, consisting of a 1 week screening period at the site, a 26 week treatment period, and a 26 week extension period.

Enrollment: 609 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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, α 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 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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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609 participants in 2 patient groups

Toujeo

Experimental group

Description:

Toujeo will be administered once daily in addition to non-insulin antidiabetic agents

Treatment:

Drug: insulin glargine (U300)

"Standard of care" commercially available basal insulin

Active Comparator group

Description:

Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir, and Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to non-insulin antidiabetic agents

Treatment:

Drug: insulin degludec

Drug: insulin glargine (U100)

Drug: insulin detemir

Drug: NPH insulin