A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulins in Insulin Naïve Patients Initiating Insulin

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: insulin glargine (U300); Drug: insulin glargine (U100); Drug: NPH insulin; Drug: insulin detemir; Drug: insulin degludec

• Registration Number: NCT02967224
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

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

Secondary Objectives:

* To demonstrate superiority of Toujeo versus "standard of care" basal insulin if noninferiority 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 \[as defined by the American Diabetes Association (ADA\] 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 hypoglycemic control subscale (HCS)

* Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.

Detailed 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.

Study Timeline

• Study Start: 2015-11-05
• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-18
• Primary Completion: 2017-10-16
• Study Completion: 2017-10-16
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 705

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Standard of care" commercially available basal insulin	NPH insulin	Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir or Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to noninsulin antidiabetic agents
Toujeo	insulin glargine (U300)	Toujeo will be administered once daily in addition to noninsulin antidiabetic agents
"Standard of care" commercially available basal insulin	insulin glargine (U100)	Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir or Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to noninsulin antidiabetic agents
"Standard of care" commercially available basal insulin	insulin degludec	Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir or Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to noninsulin antidiabetic agents
"Standard of care" commercially available basal insulin	insulin detemir	Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir or Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to noninsulin antidiabetic agents

Primary Outcome Measures

Name	Time	Method
Change in HbA1c (percentage %)	Baseline to 6 Months

Secondary Outcome Measures

Name	Time	Method
Percentage of patients whose HbA1c decreased at least 1%	At Month 6 and maintained at Month 12
Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%,<8.0%)	At Month 6 and Month 12
Percentage of patients requiring intensification	At Month 6 and Month 12
Time to intensification	At Month 6 and Month 12
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	At Month 6 and Month 12
Change in HbA1c (percentage %)	Baseline to Month 12
Change in fasting plasma glucose	Baseline to Month 6 and Month 12
Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy)	At Month 6 and Month 12
Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not	At Month 6 and Month 12
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	At Month 6 and Month 12

Trial Locations

Locations (128)

Investigational Site Number 076-001; 🇧🇷 Curitiba, Brazil

Investigational Site Number 076005; 🇧🇷 Fortaleza, Brazil

Investigational Site Number 076004; 🇧🇷 Fortaleza, Brazil

Investigational Site Number 076009; 🇧🇷 Rio de Janeiro, Brazil

Investigational Site Number 076008; 🇧🇷 Sao Paulo, Brazil

Investigational Site Number 076011; 🇧🇷 São José dos Campos, Brazil

Investigational Site Number 076007; 🇧🇷 São paulo, Brazil

Investigational Site Number 076003; 🇧🇷 São Paulo, Brazil

Investigational Site Number 076010; 🇧🇷 Taguatinga, Brazil

Investigational Site Number 250060; 🇫🇷 Alencon Cedex, France

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