NCT02967211|CompletedPhase 4

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

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

Sanofi ClinicalTrials.gov

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3 other identifiers

LPS140602015-001832-39U1111-1170-8132

Study Type

interventional

Target

609

Locations

10 countries

Sites

118

Timeline

RegisteredNov 2016

StartedDec 2015

CompletionOct 2017

Brief Summary

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.

Trial Health

On Track

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

609

participants targeted

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

Timeline

Completed

Started Dec 2015

Typical duration for phase_4 diabetes-mellitus-type-2

Geographic Reach

10 countries

118 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

1.8 years study duration

Study Start

First participant enrolled

December 21, 2015

Completed

11 months 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 20, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2017

Completed

Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

1.8 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
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 non-insulin antidiabetic agents

Drug: insulin glargine (U300)

"Standard of care" commercially available basal insulin

ACTIVE COMPARATOR

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

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