Ozempic vs. Standard Care: A Practical Type 2 Diabetes Trial
By Jeemin Kwon
A trial is enrolling over 2,000 people in any Anthem health plan with type 2 diabetes
Clinical Trials Identifier: NCT03596450
Trial name: Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population with Type 2 Diabetes – A Randomized Pragmatic Trial
Diabetes type: Type 2
What the trial is testing: Participants will either receive Ozempic (semaglutide), a once-weekly injectable medication that has been approved for use in type 2 diabetes, or standard of care, which could mean any standard diabetes medication such as TZDs (Avandia, Actos), SUs (glipizide, gliclazide, etc.) SGLT-2 inhibitors (Jardiance, Farxiga, Invokana, etc.), other GLP 1 agonists (Victoza, Trulicity, Bydureon), etc.
What the trial is measuring: Researchers will look at change in A1C, number of hypoglycemic (low blood sugar) events, body weight, and blood pressure; participants will also fill out questionnaires on treatment satisfaction and other quality of life measures.
Why is this new/important? While Ozempic is already approved around the world for adults with type 2 diabetes, manufacturers often continue studies in “real-world” settings to look at efficacy and safety outcomes outside of carefully controlled clinical trial settings. The hope is to better understand how someone with diabetes does on Ozempic under normal care conditions. In previous trials, Ozempic has shown impressive efficacy: A1C has dropped by nearly 2% (e.g., from 8.2% to 6.4%) and users have lost 5-7% of their bodyweight.
Participants enrolled in the study will not have to pay for the medications taken for the purposes of this trial.
Trial length: Two years
Trial locations: The trial is enrolling over 2,000 people across various trial locations. Currently, the only open site is in Georgia, but more sites will be added over time; the location information will be updated here. Can we check on this routinely an update this?
Select eligibility criteria include:
- 18 – 65 years old
- Current member of an Anthem health plan
- Taking metformin
- Cannot be taking any diabetes medications other than metformin (TZDs, SUs, SGLT-2 inhibitors, DPP-4 inhibitors, GLP-1 agonists, all insulins) 30 days before trial eligibility assessment
Where to get more information: Contact Novo Nordisk at 886-867-7178 or email them at firstname.lastname@example.org.