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Treatment of exercise-induced hypoglycemia in type 1 and insulin using type 2 diabetes

Pending Publication Date: 2021-01-14
XERIS PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patent text is about the pH environment that allows a peptide to be stable and soluble in high amounts. It also explains what an excipient is and how it can be used to improve the stability, solubility, and therapeutic effects of a medication. Excipients can enhance the stability, reduce viscosity, improve solubility, adjust tonicity, and enhance the overall stability of the medication. They can also be used in the manufacturing process to improve the handling and stability of the medication.

Problems solved by technology

However, blood glucose stability during exercise, and for up to 12-24 hours in recovery, remains a major challenge (West et al.
To reduce the incidence of hypoglycemia during and immediately after exercise, patients are recommended to reduce their bolus dose at the meal preceding exercise by 25-75% (Chu et al., Physiol Sports Med 39:64-77, 2011); however, this approach frequently results in pre-exercise hyperglycemia, particularly if the exercise is performed 2 hours or more after the meal (West et al.
If insulin administration occurs to correct post-exercise meal-related hyperglycemia (often called “rebound” hyperglycemia), severe post-exercise hypoglycemia can occur which may even result in death (Tanenberg et al., Endocr Pract.
9(1):24-34, 1999), excessive intake defeats the ability of the patient to have a negative caloric balance, thereby limiting the capacity for patients to maintain or lose body weight.
This is a somewhat cumbersome and unpredictable task that is usually not performed correctly, even by the most educated and motivated patients.

Method used

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  • Treatment of exercise-induced hypoglycemia in type 1 and insulin using type 2 diabetes
  • Treatment of exercise-induced hypoglycemia in type 1 and insulin using type 2 diabetes
  • Treatment of exercise-induced hypoglycemia in type 1 and insulin using type 2 diabetes

Examples

Experimental program
Comparison scheme
Effect test

example 1

Use of Mini-Dose Glucagon to Prevent Exercise—Induced Hypoglycemia in Type 1 Diabetes (T1D)

[0091]An example of one study to assess the effectiveness of mini-dose glucagon in the prevention or amelioration of exercise-induced hypoglycemia in type 1 diabetes (T1D) can include a randomized, 4-way crossover trial.

[0092]Visit Schedule. (1) Screening / Baseline Visit. This visit will be used to assess eligibility and can include determination of VO2 max for fitness evaluation and for the determination of exercise intensity for the study. (2) Randomized Crossover Trial. Each participant will undergo four aerobic exercise sessions (in random order), with different strategies for glucose regulation that include: (i) Control: Fasted exercise, no basal insulin reduction; (ii) Strategy 1: Fasted exercise, basal insulin reduction only (50% reduction in basal rate five minutes before exercise, for the duration of the exercise); (iii) Strategy 2: Fasted exercise, no basal adjustment+pre-exercise glu...

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Abstract

Certain embodiments are directed to methods for treating, ameliorating, or preventing exercise-induced or exercise-associated hypoglycemia comprising administration to a subject in need thereof a formulation(s) of glucagon or glucagon analog in an amount effective to treat, ameliorate, or prevent the condition. The subject can be administered a glucagon or a glucagon analog composition 1, 5, 10, 15 to 20, 25, 30 minutes prior to initiation of exercise.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Application No. 61 / 609,964, filed on Dec. 22 2017, the content of which is incorporated into the present application by reference.BACKGROUND OF THE INVENTIONA. Field of the Invention[0002]The invention generally concerns compositions and methods related to physiology and medicine. In particular the compositions and methods are related to treating a certain instance of hypoglycemia.B. Description of Related Art[0003]Exercise is at the cornerstone of type 1 diabetes (T1D) management (Chu et al., Physiol Sports Med 39:64-77, 2011). However, blood glucose stability during exercise, and for up to 12-24 hours in recovery, remains a major challenge (West et al. J Sports Sci 28:781-88, 2010). A fear of hypoglycemia deters many patients from engaging in aerobic exercise (Brazeau et al. Diabetes Care. 11 2108-9, 2008). For those who choose to exercise on a regular basis, hypoglycemia is a comm...

Claims

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Application Information

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IPC IPC(8): A61K38/26A61K47/10A61K47/26A61K47/02A61P3/10A61K9/00
CPCA61K38/26A61K47/10A61K9/0053A61K47/02A61P3/10A61K47/26A61K47/20A61K9/0014A61K9/0019A61K9/0021A61K9/0043A61K9/0073A61K9/06A61K9/08A61K9/10A61K9/107
Inventor PRESTRELSKI, STEVENNEWSWANGER, BRETTCUMMINS, MARTINRIDDELL, MICHAEL
Owner XERIS PHARMA
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