Flexible Insulin Dosing Regimen for Diabetes

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Solution Overview

Problem

Current insulin treatment regimens for diabetes, particularly in type 1 and type 2 diabetes, often require fixed daily dosing schedules, which can be inconvenient and lead to non-compliance, especially for individuals with irregular lifestyles or schedules, and may not provide optimal glycemic control.

Innovation Solution

A novel insulin administration scheme using a derivative of human insulin, LysB29(Nε-hexadecandioyl-γ-Glu) des(B30) human insulin, which allows for flexible dosing intervals varying from 8 to 40 hours, enabling administration at intervals that are at least 1.3 times or no more than 0.85 times the mean interval, without adjusting dosages, to improve convenience and maintain glycemic control.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If fixed daily dosing schedules are used for insulin treatment, 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 the dynamics principle by transitioning from fixed dosing intervals to flexible dosing intervals. The insulin derivative maintains stable blood glucose levels even when dosing intervals vary dynamically between 12-36 hours, allowing patients to adjust injection times to their individual schedules while preserving glycemic control.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent employs parameter changes by modifying the dosing interval parameter from a fixed value to a variable range (12-36 hours). The insulin derivative's extended half-life enables this parameter change while maintaining therapeutic effectiveness, resolving the contradiction between fixed scheduling requirements and patient lifestyle flexibility.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If fixed dosing intervals are required for long acting insulin, then metabolic control is optimized, but adaptability to individual patient lifestyles deteriorates

Engineering Contradiction:
Improvemetabolic controlVSAvoidlifestyle adaptability
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent implements dynamics by enabling the dosing interval to adapt dynamically to patient needs. The insulin derivative maintains its metabolic control function across a range of intervals (12-36 hours), allowing the treatment regimen to adapt to varying patient schedules without compromising efficacy.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent applies universality by designing an insulin derivative that functions effectively across multiple dosing scenarios. The single injection regimen works universally for patients with different lifestyles and schedules, eliminating the need for precise timing while maintaining metabolic control.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Reliability

If multiple daily insulin injections are administered, then glycemic control improves, but device complexity and treatment burden increase

Engineering Contradiction:
Improveglycemic controlVSAvoidtreatment regimen complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent extracts the need for multiple dosing administrations by using a single injection of the insulin derivative. This single injection provides prolonged glycemic control, removing the complexity of multiple daily injections while maintaining effective metabolic control.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent applies preliminary action by providing a single upfront injection that delivers sustained insulin activity over an extended period. This preliminary dosing action covers the entire dosing interval (12-36 hours), eliminating the need for subsequent adjustments or additional injections during the interval.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP2632478B1Treating diabetes melitus using insulin injections administered with varying injection intervals
Publication Date: 2019.07.24 NOVO NORDISK AS
  • EP2632478B1 patent drawingFigure 1
  • EP2632478B1 patent drawingFigure 2

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.