# Dual Agonist Insulins for Treating Diabetics with Impaired Awareness ofHypoglycemia (IAH)

> **NIH NIH R44** · AMIDEBIO, LLC · 2024 · $929,940

## Abstract

SUMMARY/ABSTRACT
Diabetes is a global health crisis. Depending on the type of statistical methodology used, the world-wide
incidence of the most common type of diabetes, adult-onset or Type II, is estimated to be in the range of 285
million. In both Type I and Type II diabetics, glycemic control is paramount as the inability to maintain glycemic
control results in increased risk of cardiovascular complications as well as several secondary complications
including neuropathy, nephropathy and retinopathy, that often lead to amputations, dialysis and blindness.
Hypoglycemia is a common adverse effect of insulin therapy and recent data shows that in the US alone almost
100k visits to the emergency department and more than 25K hospitalizations are due to insulin related
hypoglycemia. Not surprisingly, exposure to hypoglycemia can induce a form of habituation leading to impaired
awareness of hypoglycemia (IAH). IAH is a severe complication that often results in death due to patients being
unresponsive and unable to self-administer glucose or emergency glucagon. Currently, there is no available
approach to combating IAH. In our preliminary work we have designed and tested a series of novel dual agonist
drugs candidates we term molecular artificial pancreas systems (mAPS). Our studies have demonstrated the
mechanism of action and the ability of mAPS to prevent hypoglycemia at very high doses. In this Direct-to-
Phase II project we will pursue manufacturing, formulation, efficacy validation, and safety studies on 3 lead
candidates to identify a first in class dual agonist biologic suitable for safely treating Type I and Type II diabetics
experiencing IAH.

## Key facts

- **NIH application ID:** 11007128
- **Project number:** 1R44DK141357-01
- **Recipient organization:** AMIDEBIO, LLC
- **Principal Investigator:** Pawel Fludzinski
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $929,940
- **Award type:** 1
- **Project period:** 2024-09-01 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11007128

## Citation

> US National Institutes of Health, RePORTER application 11007128, Dual Agonist Insulins for Treating Diabetics with Impaired Awareness ofHypoglycemia (IAH) (1R44DK141357-01). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/11007128. Licensed CC0.

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