CA-3164991-C - AUTOMATIC DRUG DELIVERY SYSTEM FOR DELIVERY OF A GLP-1 THERAPEUTIC

CA3164991CCA 3164991 CCA3164991 CCA 3164991CCA-3164991-C

Abstract

The disclosed embodiments are directed to a wearable automatic drug delivery device configured to provide basal dosing of GLP-1 or co-formulation of GLP-1 and insulin. The size and frequency of the basal doses may be controlled by a medication delivery algorithm resident on the wearable drug delivery device based on a basal dosing history and readings from a continuous glucose monitor monitoring the glucose levels of the wearer of the device.

Inventors

Trang LY
Matt Rainville
M. Thomas Andersen

Assignees

INSULET CORPORATION

Dates

Publication Date: 20260505
Application Date: 20220111
Priority Date: 20210219

Claims (1)

69 CLAIMS 1. A wearable drug delivery device comprising: a controller; software, for execution by the controller, the software implementing a medication delivery algorithm; a single reservoir; a quantity of a GLP-1 Therapeutic, contained in the single reservoir; a pump mechanism, controlled by the medication delivery algorithm and in fluid communication with the single reservoir; and a patient interface, in fluid communication with the pump mechanism; wherein doses of the GLP-1 Therapeutic are delivered to a wearer of the wearable drug delivery device as directed by the medication delivery algorithm; and wherein the medication delivery algorithm is further configured to: accept an input from the wearer indicating that the wearer has experienced an adverse event; suspend delivery of the GLP-1 Therapeutic; and resume delivery of the GLP-1 Therapeutic automatically after a predetermined period of time or when a further input is received from the wearer indicating that the adverse event has passed. 70 2. The wearable drug delivery device of claim 1, wherein the GLP-1 Therapeutic comprises a co-formulation of GLP-1 and insulin. 3. The wearable drug delivery device of claim 1 or 2, wherein the doses of the GLP-1 Therapeutic includes bolus doses of the GLP-1 Therapeutic. 4. The wearable drug delivery device of claim 1 or 2, wherein the doses comprise basal doses and/or bolus doses, and suspending delivery stops delivery of all basal doses and bolus doses of the GLP-1 Therapeutic. 5. The wearable drug delivery device of any one of claims 1 to 4, wherein the predetermined period of time is 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, or 3 hours. 6. The wearable drug delivery device of claim 5, wherein the predetermined period of time is a user-selected predetermined period of time received through the patient interface. 7. The wearable drug delivery device of claim 5, wherein the predetermined period of time is a default duration. 8. The wearable drug delivery device of claim 1 or 2, wherein suspending delivery of the GLP-1 Therapeutic comprises reducing an amount of the GLP-1 Therapeutic that is delivered. 71 9. The wearable drug delivery device of claim 8, wherein the amount of the GLP-1 Therapeutic is reduced by 25%, 50%, or 75%. 10. The wearable drug delivery device of claim 9, wherein the reduced amount is a user-selected reduced amount received through the patient interface. 11. The wearable drug delivery device of claim 9, wherein the reduced amount is a default amount. 12. The wearable drug delivery device of any one of claims 1 to 11, wherein resuming delivery of the GLP-1 Therapeutic comprises ramping up delivery of the GLP-1 Therapeutic from a current rate of delivery to a previous rate of delivery over a second predetermined period of time. 13. The wearable drug delivery device of claim 12, wherein the second predetermined period of time is 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, or 3 hours. 14. The wearable drug delivery device of claim 12 or 13, wherein the amount of GLP-1 Therapeutic delivered over the second predetermined period of time increases in a substantially linear manner. 72 15. The wearable drug delivery device of any one of claims 1 to 14, further comprising a user interface element corresponding to a side effect mode of the wearable drug delivery device, and accepting the input from the wearer comprises receiving a selection of the element corresponding to the side effect mode.

Description

1 AUTOMATIC DRUG DELIVERY SYSTEM FOR DELIVERY OF A GLP-1 THERAPEUTIC [0001] This application is a divisional application divided from Canadian Patent Application 3,145,377 filed on January 11, 2022. BACKGROUND [0002] Glucagon Like Peptide 1 receptor agonists (GLP-1s) for the treatment of Type 2 diabetes first entered the market in 2005 and their use has grown significantly since that time. GLP-1s are known as an efficacious tool to reduce blood glucose levels and lower body weight, while providing cardiovascular benefits for people living with type 2 diabetes. The GLP-1 receptor agonists currently approved in the United States for the treatment of type 2 diabetes include exenatide (administered twice daily via a pen), liraglutide and lixisenatide (administered once daily via a pen), and once-weekly agents exenatide extended-release, albiglutide, semiglutide and dulaglutide, all delivered via a pen. [0003] GLP-1s drive favorable efficacy via several unique mechanisms which have benefits for diabetes management. In particular, and most importantly, GLP-1s lower the glucose levels in the patient. In addition, they tend to suppress post-prandial glucagon release, delay stomach emptying, and increase insulin sensitivity. Additionally, GLP-1 receptor agonists can help with weight loss and result in less hypoglycemia when used in combination with insulin. As disclosed in this application, using a fixed-ratio treatment of GLP-1 and insulin via continuous subcutaneous infusion can increase patient use and further improve glycemic control. 2 [0004] There are several reasons why Type 2 patients have a low adherence to or tend to discontinue therapy altogether. The process of transitioning to an injectable therapy is challenging and a significant milestone for both patients and HCPs. Patients tend to resist the idea of moving beyond oral therapies as injections are often perceived by the patient as a signal for a worsening disease state. In addition, GLP-1s are well known for their unpleasant gastrointestinal side effects, often causing the patient to experience nausea. To reduce the severity of these adverse events, medication dosing can be slowly titrated, but side effects remain. Nausea is the most common adverse effect reported within the GLP-1 class, affecting up to 50% of users. This negatively impacts patient adherence and creates additional labor for the HCP practice in the form of both clinical support and patient counseling. Following adverse gastrointestinal events, the method and frequency of administration precludes many patients from beginning and staying on therapy. [0005] A number of systems provide basal delivery of drugs, such as GLP-1, insulin, chemotherapy drugs, pain management drugs and the like. Throughout a day, the basal insulin needed for a diabetic user to maintain a stable fasting glucose target setting varies 20-30% or more at different times. Thus, it is important that the basal delivery of the drugs be based on a time-dependent basal profile learned by the system based on various histories regarding the delivery of the drug to the patient. 3 DEFINITIONS [0006] As used herein, the term “GLP-1 Therapeutic” is defined to include formulations of GLP-1 and co-formulations of GLP-1 and insulin, in any concentrations. [0007] As used herein, the term “drug” is defined to include GLP-1 Therapeutics, insulin, chemotherapy drugs, pain relief drugs (e.g., morphine), blood pressure medication, hormones, methadone, and any other single drug or combination thereof to be administered in liquid form. SUMMARY [0007a] Certain exemplary embodiments provide a wearable drug delivery device comprising: a controller; software, for execution by the controller, the software implementing a medication delivery algorithm; a single reservoir; a quantity of a GLP-1 Therapeutic, contained in the single reservoir; a pump mechanism, controlled by the medication delivery algorithm and in fluid communication with the single reservoir; and a patient interface, in fluid communication with the pump mechanism; wherein doses of the GLP-1 Therapeutic are delivered to a wearer of the wearable drug delivery device as directed by the medication delivery algorithm; and wherein the medication delivery algorithm is further configured to: accept an input from the wearer indicating that the wearer has experienced an adverse event; suspend delivery of the GLP-1 Therapeutic; and resume delivery of the GLP-1 Therapeutic automatically after a predetermined CA 3164991 4 period of time or when a further input is received from the wearer indicating that the adverse event has passed. [0008] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter. [0009] The co-infusion o