You are here

An Ultra-Stable Insulin Analog with Intrinsic Basal-Bolus Action

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43DK103445-01
Agency Tracking Number: R43DK103445
Amount: $300,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIDDK
Solicitation Number: PA13-234
Timeline
Solicitation Year: 2014
Award Year: 2014
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
10000 Cedar Avenue
CLEVELAND, OH 44106-2119
United States
DUNS: 963396747
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 BRUCE FRANK
 (317) 846-4233
 bruce@thermalin.com
Business Contact
 RICHARD BERENSON
Phone: (617) 695-0523
Email: rick@thermalin.com
Research Institution
 Stub
Abstract

DESCRIPTION (provided by applicant): Pre-mixed formulations of soluble prandial insulin analogs and NPH micro-crystalline suspensions provide a simplified and cost-effective basal-bolus regimen for patients with Type 2 diabetes mellitus (T2DM) not effectively controlled by basal insulin therapy alone. Such twice-daily products (in vials or pre-filled in pens) account for gt 2B in sales in the developed world, and their use is rapidly growing in the developing world. The market leaders are Novo-Nordisk (NovoMix(r) 30 in which insulin aspart is formulated 30% as a soluble zinc hexamer and 70% as an NPH micro-crystalline suspension) and Eli Lilly and Co (Humalog(r) Premixed Insulin in which insulin lispro is formulated 25% as a soluble zinc hexamer and 75% asan NPH micro-crystalline suspension; a 50/50 product is also available). Despite their popularity and clinical utility with appropriate patients, these products are complicated to manufacture, not mixable with other insulin products, fixed in their ba

* Information listed above is at the time of submission. *

US Flag An Official Website of the United States Government