Turning an Injection into a Pill? New Trial Investigates a Novel Type 2 Diabetes Drug
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 Trials Identifier: NCT02653599
Trial Name: A Study to Evaluate Safety and Efficacy of TTP273 for 12 Weeks in Subjects with Type 2 Diabetes
Diabetes Type: Type 2 Diabetes
What it’s testing: This phase 2 trial will assess the efficacy and safety of an orally administered (i.e., taken as a pill) GLP-1 agonist called TTP273 in adults with type 2 diabetes on a stable dose of metformin. Approximately 156 study participants will be randomized to either receive once-daily TTP273, twice-daily dose of TTP273, or placebo – all participants will continue a stable dose of metformin throughout the study.
What it’s measuring: The study is primarily focused on the change in A1c and other outcomes associated with glycemic control, as well as change in body weight and lipids.
Why is this new/important: GLP-1 agonist drugs to date, including Trulicity, Victoza, Byetta/Bydureon, and Tanzeum, have been administered as injections (usually once daily or once weekly). TTP273is a GLP-1 agonist drug in development that would be taken as a pill. How is it possible? TTP273 is a “small molecule” drug, allowing it to be packaged in pill-form, whereas other GLP-1 agonists are peptide drugs that are larger molecules that must be injected, because they are too fragile to survive in the aggressive environment of the stomach. In addition to strong glucose-lowering effects, previous studies with TTP273 seem to indicate a reduced incidence of nausea compared with injectable GLP-1 agonists.
Trial Length: 14 weeks
Trial Location(s): The trial is currently recruiting in the following US states: CA, FL, GA, IL, MI, NE, NC, NY, OH, OK, TX, and WA.
Do you qualify?
- Age 18 to 75
- Type 2 diabetes on stable metformin for at least 3 months
- Males or female of non-childbearing potential
- A1c between 7.5 and 10%
- Generally stable health
Exclusion criteria include:
- Use of any diabetic agent except metformin within three months prior to screening
- History of pancreatitis
- History of MEN-2 or family history of medullary thyroid cancer
- Previous surgical treatment for obesity
For a full list of the trial’s inclusion criteria, please visit its webpage here.
Where to get more information: For more information about the trial, please contact Chris Dvergsten, Ph.D., or Leslie Humphries, BSMT at 336-841-0300, ext. 120, or email [email protected].