Can Invokana Help with Weight Management in People with Type 2 Diabetes?
Welcome to trial watch, where we keep an eye on the latest and greatest trials going on in the field of diabetes. Here, you can learn about new therapies and devices currently under study, and learn more about participating in these trials. Trial participants can get early access to new treatments, receive care at clinical trial centers, and are usually compensated for their time. You can read more about clinical trials at the “Center Watch” volunteer page or the ClinicalTrials.Gov information page.
Clinical Trial Identifier: NCT02360774
Trial name: Mechanisms of Weight Loss with SGLT-2 Inhibition
Diabetes type: Type 2 diabetes.
What it’s testing: This study will look at the SGLT-2 inhibitor Invokana’s (canagliflozin) effects on body weight in overweight or obese people with type 2 diabetes. This trial is a “post-marketing” trial, since the blood-sugar-lowering drug has been available in the US since 2013.
What the trial is measuring: The primary outcome is a change in body weight. The researchers will examine if people given Invokana lose more weight (relative to their starting body weight) than those given a placebo (inactive) pill.
Why this is new/important: Clinical trials have previously shown that SGLT-2 inhibitor drugs can cause weight loss in some patients, but currently these drugs are only approved to lower blood glucose levels. This trial will bring more information on any potential weight loss benefits of Invokana. The results could potentially shape future FDA regulatory decisions about the drug (e.g., perhaps adding “weight loss” to its official prescribing information), or even whether it could be marketed as a weight loss drug.
Trial Length: 18 weeks.
Trial Location: The trial is located at the Beth Israel Deaconess Medical Center in Boston, MA
Do you qualify? To qualify, one must be between 18-75 years old, have type 2 diabetes, have a BMI between 25 and 45 and an A1c between 6.5% and 9%. Participants cannot currently be using insulin or GLP-1 agonists (Byetta, Bydureon, Tanzeum, Trulicity, Victoza) as part of their treatment.