NCT02967224|CompletedPhase 4

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

Reach-Control

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

Sanofi ClinicalTrials.gov

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3 other identifiers

LPS139312015-001831-18U1111-1170-8104

Study Type

interventional

Target

705

Locations

7 countries

Sites

128

Timeline

RegisteredNov 2016

StartedNov 2015

CompletionOct 2017

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

705

participants targeted

Target at P75+ for phase_4 diabetes-mellitus-type-2

Timeline

Completed

Started Nov 2015

Typical duration for phase_4 diabetes-mellitus-type-2

Geographic Reach

7 countries

128 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

Study Start

First participant enrolled

November 5, 2015

Completed

1 year until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2017

Completed

Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

1.9 years

First QC Date

November 16, 2016

Last Update Submit

April 21, 2022

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c (percentage %)
Baseline to 6 Months

Secondary Outcomes (11)

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 who achieve target HbA1c (<6.5%, <7%, <7.5%,<8.0%)
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
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
+6 more secondary outcomes

Study Arms (2)

Toujeo

EXPERIMENTAL

Toujeo will be administered once daily in addition to noninsulin antidiabetic agents

Drug: insulin glargine (U300)

"Standard of care" commercially available basal insulin

ACTIVE COMPARATOR

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

Drug: insulin glargine (U100)Drug: NPH insulinDrug: insulin detemirDrug: insulin degludec