Insulin Dimer-Incretin Conjugates for Lower Hypoglycemia Risk

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Solution Overview

Problem

Current insulin therapies, including long-acting insulins, are not optimized for physiological basal insulin release, leading to increased hypoglycemia risk and limited glycemic control due to relative over-insulinization of peripheral tissues.

Innovation Solution

Development of insulin dimers conjugated to peptides with incretin activity, such as GLP-1 or GIP, through a linking moiety, forming an insulin dimer that acts as a partial agonist at the insulin receptor, providing tissue-specific glucose regulation with reduced hypoglycemia risk.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If long-acting insulins are used to regulate basal glucose levels, then glycemic control is improved, but hypoglycemia risk increases due to over-insulinization of peripheral tissues

Engineering Contradiction:
Improveglycemic controlVSAvoidhypoglycemia risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent divides the insulin molecule into dimers (two insulin molecules linked together) and further segments functionality by conjugating to incretin peptides. This segmentation allows the insulin dimer to provide basal glucose regulation while the incretin component provides glucose-dependent glucose lowering, reducing hypoglycemia risk through functional division

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent creates a composite therapeutic agent by conjugating insulin dimers with incretin peptides (GLP-1, GIP, or glucagon). This composite structure combines the glucose-lowering effects of insulin with the glucose-dependent regulation of incretins, achieving improved glycemic control with reduced hypoglycemia risk through synergistic interaction of multiple components

Inventive Principle:
Principle #40Composite materials

2Duration of action of moving object

If insulin analogs are developed to improve PK flatness, then duration of action is extended, but relative over-insulinization of peripheral tissues persists

Engineering Contradiction:
Improveduration of actionVSAvoidover-insulinization of peripheral tissues
Core Design Contradiction:
Duration of action of moving objectVSObject-affected harmful factors

Solution Approach 1:

The patent segments the insulin molecule into dimers and conjugates to incretin peptides, creating a composite agent where the insulin dimer provides extended duration action while the incretin component provides glucose-dependent regulation that prevents peripheral over-insulinization

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent changes the molecular parameters of insulin by forming dimers (altering aggregation state) and conjugating to incretin peptides (altering molecular weight and structure). These parameter changes extend duration of action while the incretin component's glucose-dependent mechanism prevents peripheral over-insulinization

Inventive Principle:
Principle #35Parameter changes

3Reliability

If rapid-acting insulin analogs are used to control post-prandial hyperglycemia, then post-meal glucose control is improved, but narrow therapeutic index to hypoglycemia remains

Engineering Contradiction:
Improvepost-prandial glucose controlVSAvoidnarrow therapeutic index
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent creates composite insulin dimer-incretin conjugates where the incretin component provides glucose-dependent glucose lowering that expands the therapeutic index. The composite agent maintains effectiveness for post-prandial control while the incretin's glucose-sensing mechanism prevents hypoglycemia, widening the safety margin

Inventive Principle:
Principle #40Composite materials

Data Source

PatentEP3448417B1Insulin dimer-incretin conjugates
Publication Date: 2025.11.12 MERCK SHARP & DOHME LLC
  • EP3448417B1 patent drawingFigure 1
  • EP3448417B1 patent drawingFigure 2A
  • EP3448417B1 patent drawingFigure 2B

AI summary

Insulin dimers conjugated to peptides having at least one incretin activity are disclosed.