How Does Next-Gen Basal Insulin Toujeo Work in Type 2 Diabetes?
By Dalton Price
A real-world trial in 3,000+ participants currently enrolling participants with type 2 diabetes
Clinical Trials Identifier: NCT02451137
Trial name: A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)
Diabetes type: Type 2
What the trial is testing: The aim of this study is to demonstrate the clinical benefit of Toujeo, Sanofi’s once-daily long-acting basal insulin, in comparison to other available basal insulins Levemir and Lantus (read more about basal insulins here).
What the trial is measuring: After six months, the trial will measure A1c levels and instances of documented hypoglycemia, defined as blood sugar levels less than 70 mg/dl in this study.
Why this is important: Toujeo is currently approved for use in adults with diabetes as a daily basal insulin injection. Previous phase 3 clinical trials had shown that Toujeo is slightly better than Lantus in lowering A1c but with mixed results for reducing risk for hypoglycemia. (Compared to Lantus, which has 100 units of insulin glargine in each milliliter, Toujeo is more concentrated with 300 units of insulin per milliliter.) This real-world trial may provide more conclusive information on whether Toujeo has any hypoglycemia benefits.
Trial length: Up to 53 weeks
Trial location: 393 locations throughout the US and Canada, including San Diego, New York City, Dallas, and Miami. Visit this site and click the “Find A Location” tab to see the full list.
Do you qualify?
Diagnosed with type 2 diabetes for at least one year prior to screening
An A1c between 8% and 11%
Treatment with two or more of the following: metformin, sulfonylureas (Glucotrol, Amaryl, glyburide), TZDs (Avandia or Actos), DPP-4 inhibitors (Januvia, Onglyza, Tradjenta, etc), SGLT-2 inhibitors (Invokana, Farxiga, Jardiance), or GLP-1 agonists (Victoza, Trulicity, Bydureon, etc).
18 years or older
Exclusion criteria (partial list) include:
A1c less than 8.0% or greater than 11.0%
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 shorter life expectancy
Use of any product containing insulin since the time of diagnosis with type 2 diabetes other than temporary use during pregnancy or hospitalization
Pregnancy or lactation
For a full list of the trial’s inclusion and exclusion criteria and additional information, please visit its website here.
To enroll: Enter your location on this site and complete the steps to be sent enrollment information.