NCT02967224: Reach-Control

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

Completed Phase 4 Last updated 25 April 2022

What this trial tests

Phase 4 trial testing insulin glargine (U300) in Diabetes Mellitus, Type 2 in 705 participants. Completed in 16 October 2017.

Timeline

5 November 2015

Primary endpoint
16 October 2017

16 October 2017

Quick facts

Lead sponsor	Sanofi
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	705
Start date	5 November 2015
Primary completion	16 October 2017
Estimated completion	16 October 2017
Sites	128 locations across France, Ireland, United Kingdom, Germany, Romania, Spain, Brazil

Drugs / interventions tested

• insulin glargine (U300) — full drug profile →
• insulin glargine (U100)
• NPH insulin — full drug profile →
• insulin detemir (INSULIN DETEMIR) — full drug profile →
• insulin degludec (INSULIN DEGLUDEC) — full drug profile →

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Sanofi — full company profile →

Who can join

18 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus.
   Freemantle N, Mauricio D, Giaccari A, Bailey T, et al · · 2020 · cited 17× · PMID 31865758 · DOI 10.1080/03007995.2019.1708287
2. Clinical Trials With Pragmatic Elements: A Review of Use Cases and Real-World Data Utilization.
   Su L, Chen L, Betigeri S, Dreyer N, et al · · 2025 · cited 3× · PMID 40827586 · DOI 10.1002/cpt.70033