Flexible Insulin Dosing for Glycemic Control

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Solution Overview

Problem

Current insulin treatment regimens for diabetes, particularly in diabetes mellitus and hyperglycemia, often require fixed dosing schedules, which can be inconvenient and lead to non-compliance, especially for individuals with irregular lifestyles, and may not maintain optimal glycemic control.

Innovation Solution

A method involving the administration of insulin analogues or derivatives with a prolonged profile of action at varying intervals, allowing for flexible dosing that adapts to individual needs and lifestyles without compromising glycemic control or safety.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If fixed dosing schedules are used for insulin administration, then glycemic control can be maintained, but patient compliance deteriorates due to inconvenience for individuals with irregular lifestyles

Engineering Contradiction:
Improveglycemic controlVSAvoidpatient compliance
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent applies dynamics by transitioning from fixed, static dosing schedules to flexible, dynamic dosing intervals. The insulin derivative's prolonged action profile enables dosing intervals that can be adjusted based on patient lifestyle needs while maintaining therapeutic effectiveness, resolving the contradiction between maintaining glycemic control and improving patient compliance.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent changes the temporal parameter of dosing intervals from fixed to variable. By using insulin derivatives with prolonged action profiles, the patent enables dosing intervals to be extended or adjusted without compromising glycemic control, thereby improving ease of operation and patient compliance while maintaining reliability of therapeutic effect.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If flexible dosing intervals are used for insulin administration, then patient compliance improves, but maintaining optimal glycemic control becomes more difficult

Engineering Contradiction:
Improvepatient complianceVSAvoidglycemic control
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent uses dynamics to create a flexible dosing system that adapts to patient needs. The prolonged action profile of the insulin derivative provides a dynamic buffer that maintains stable blood glucose levels even when dosing intervals are adjusted, allowing patients to comply with treatment while maintaining glycemic control.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent changes the dosing interval parameter from fixed to flexible while compensating through the prolonged action profile of the insulin derivative. This parameter change enables improved patient compliance without sacrificing glycemic control reliability, as the extended action duration of the derivative insulates against the variability introduced by flexible scheduling.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If long acting insulin is administered once or more often per day at fixed times, then basal insulin requirement is covered, but convenience deteriorates for patients with irregular lifestyles

Engineering Contradiction:
Improvebasal insulin coverageVSAvoidconvenience
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent applies dynamics by enabling transition from fixed to flexible dosing schedules. The prolonged action profile of the insulin derivative creates a dynamic system that maintains basal insulin coverage even when dosing times are adjusted, improving convenience for patients with irregular lifestyles while preserving reliable basal coverage.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent changes the dosing frequency and timing parameters from fixed to flexible. By using insulin derivatives with prolonged action profiles, the patent extends the effective duration of action, allowing patients to administer insulin at convenient times while maintaining adequate basal insulin coverage throughout the extended interval.

Inventive Principle:
Principle #35Parameter changes

4Ease of operation

If dosing intervals are extended beyond fixed schedules, then convenience improves, but risk of suboptimal metabolic control increases

Engineering Contradiction:
ImproveconvenienceVSAvoidmetabolic control
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent changes the dosing interval parameter from fixed to extended and flexible. The prolonged action profile of the insulin derivative compensates for the extended intervals, maintaining metabolically active insulin levels throughout the extended dosing period, thereby improving convenience without increasing the risk of suboptimal metabolic control.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent applies beforehand cushioning by using the prolonged action profile of the insulin derivative to create a buffer against the potential risks of extended dosing intervals. This cushioning effect ensures that even when dosing intervals are extended for convenience, adequate insulin coverage is maintained, preventing suboptimal metabolic control.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

Data Source

PatentUS10596229B2Method of treating diabetes mellitus by administration, at specifically defined intervals, of a derivative of a naturally occurring insulin or insulin analogue, the derivative having a prolonged profile of action
Publication Date: 2020.03.24 NOVO NORDISK AS
  • US10596229B2 patent drawing
  • US10596229B2 patent drawing

AI summary

The present invention relates to methods for treatment of a condition or disease where administration of insulin will be of benefit, comprising administering, to a patient in need thereof, effective dosages of an insulin, insulin analogue or derivative thereof, which exhibits a prolonged profile of action, wherein said dosages are administered at intervals of varying length.