Northerner
Admin (Retired)
- Relationship to Diabetes
- Type 1
• HinsBet's objective is to improve human insulin performance in a cost-effective way
• Phase IIa study will compare HinsBet to a fast-acting insulin analog and a regular human insulin in type 1 diabetic patients
• First Patient In planned for the first week of August
LYON, France I July 9, 2014 I Adocia (Euronext Paris: FR0011184241 - ADOC) announced today that BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte), the German regulatory agency for drugs and medical devices, has approved the initiation of a Phase IIa clinical study of HinsBet®, a fast-acting formulation of human insulin. HinsBet is a new type of prandial insulin, developed using the Company's proprietary BioChaperone® technology, that has been designed to reconcile the performance of insulin analogs with the cost-effectiveness of human insulin.
The aim of this Phase IIa clinical trial is to demonstrate that HinsBet acts faster than Humulin® (human insulin, Eli Lilly) and as fast as Humalog® (insulin lispro, Eli Lilly), allowing patients who use human insulin to achieve a better glycemic control after a meal. In this double-blind, randomized, 3 arm, crossover study, the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of HinsBet will be compared to those of Humulin and Humalog. 36 patients with type 1 diabetes will receive single 0.2 U/kg doses of HinsBet, Humulin and Humalog under automated euglycemic clamp conditions. Adocia plans to dose the first patient during the first week of August. Results are expected in Q1 2015.
http://www.pipelinereview.com/index...-acting-Human-Insulin-in-Type-1-Diabetes.html
• Phase IIa study will compare HinsBet to a fast-acting insulin analog and a regular human insulin in type 1 diabetic patients
• First Patient In planned for the first week of August
LYON, France I July 9, 2014 I Adocia (Euronext Paris: FR0011184241 - ADOC) announced today that BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte), the German regulatory agency for drugs and medical devices, has approved the initiation of a Phase IIa clinical study of HinsBet®, a fast-acting formulation of human insulin. HinsBet is a new type of prandial insulin, developed using the Company's proprietary BioChaperone® technology, that has been designed to reconcile the performance of insulin analogs with the cost-effectiveness of human insulin.
The aim of this Phase IIa clinical trial is to demonstrate that HinsBet acts faster than Humulin® (human insulin, Eli Lilly) and as fast as Humalog® (insulin lispro, Eli Lilly), allowing patients who use human insulin to achieve a better glycemic control after a meal. In this double-blind, randomized, 3 arm, crossover study, the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of HinsBet will be compared to those of Humulin and Humalog. 36 patients with type 1 diabetes will receive single 0.2 U/kg doses of HinsBet, Humulin and Humalog under automated euglycemic clamp conditions. Adocia plans to dose the first patient during the first week of August. Results are expected in Q1 2015.
http://www.pipelinereview.com/index...-acting-Human-Insulin-in-Type-1-Diabetes.html
