Representing Diversity in Diabetes: A New Type 2 Drug Trial
By Jeemin Kwon
By Jeemin Kwon
Recruiting 1,200 people with type 2 diabetes from diverse ethnic and racial backgrounds for a more thorough understanding of Soliqua’s impact on diabetes management
Clinical Trials Identifier: NCT03434119
Trial name: Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents (LixiLan-D)
Diabetes type: Type 2
What the trial is testing: The trial is testing Soliqua, a combination drug of Lantus (a basal insulin) and GLP-1 agonist Adlyxin/Lyxumia, against Lantus-only in the management of type 2 diabetes. Researchers are specifically recruiting participants who self-identify as Hispanic, Black/African American, or Asian. Compared to Lantus alone, Soliqua has been shown to drive greater A1c reductions, cause less weight gain than taking insulin alone, and reduce the risk of hypoglycemia. Soliqua is FDA-approved for adults with type 2 diabetes and has been available in pharmacies since early 2017.
What the trial is measuring: Change in A1c is the primary outcome being measured, but researchers are also interested in recording post-meal glucose levels, change in insulin dosing, body weight, instances of hypoglycemia (both below 70 mg/dl and below 54 mg/dl), and any adverse events.
Why is this new/important? It is important for clinical trial populations to reflect the diversity of the real-world population that will potentially be using the drug, as responses to any particular drug can depend on a variety of factors such as ethnicity, lifestyle, access to healthcare, and more. In previous clinical trials with Soliqua, such as LixiLan-L, as many as 92% of study participants were recorded as white, a trend commonly seen in clinical trials for many different drugs and devices. Clinical trial like this once, which recruit a more diverse population, may help better inform healthcare providers on how to best personalize diabetes management.
Trial length: 29 weeks (about 7 months)
Trial locations: This study will enroll 1,200 people with type 2, primarily in Los Angeles, CA. Participating locations will continually be updated here.
Do you qualify? Select inclusion criteria include:
Adults diagnosed with type 2 diabetes at least one year before enrolling in trial
A1c between 7.5% and 10%
Self-identifying as non-Hispanic black/African American, Hispanic, Asian (those identifying with more than one race must select one category for the trial)
Treated with any basal (long-acting) insulin, like Lantus, Levemir, Tresiba, Toujeo, NPH (“N”), etc., for at least 6 months prior to enrolling
Cannot have a fasting plasma glucose (FPG) greater than 200 mg/dl at start of trial
Cannot be regularly using mealtime insulin or a pump
BMI between 20 and 40 kg/m2 (calculate your BMI here)
Where to get more information: For more information about this trial, you can contact Sanofi, the sponsor of this trial, at [email protected].