Date: 2017-07-03
Type of
information: Initiation of the trial
phase: 3
Announcement: treatment of the first patient
Company: Zealand Pharma (Denmark)
Product: dasiglucagon (ZP4207)
Action
mechanism: glucagon analog. Dasiglucagon (ZP4207) is a glucagon peptide analog, invented and fully owned by Zealand and observed to have a favorable physical and chemical stability in liquid solution. In June 2016, dasiglucagon was proposed as an International Nonproprietary Name (pINN) for this product candidate.
Disease: severe hypoglycemia in type 1 diabetes patients
Therapeutic
area: Metabolic diseases
Country: Austria, Canada, Germany, USA
Trial
details:
Latest
news:
- • On July 3, 2017, Zealand Pharma announced the initiation of a multinational Phase 3 clinical trial of dasiglucagon in four countries (Austria, Germany, Canada and the U.S.). Phase 2 clinical results indicated that dasiglucagon rapidly increases plasma glucose (PG) levels after insulin-induced hypoglycemia, with a longer lasting and more pronounced PG increase with dasiglucagon compared to the active comparator, GlucaGen®. This potentially leads to a favorable efficacy profile of preventing recurrent hypoglycemia. Post-dosing hypoglycemia events were rare, with only two events (within six hours) with dasiglucagon, compared to nine events with GlucaGen®.
- The aim of this first Phase 3 trial is to evaluate the immunogenicity of repeated single doses of dasiglucagon (0.6 mg) following subcutaneous administration to patients with type 1 diabetes, as well as effect, safety, tolerability. Dasiglucagon will be compared with GlucaGen®, a glucagon analog marketed in powder form for reconstitution. The trial will be conducted over 15 weeks, during which 90 patients will be exposed to either dasiglucagon or GlucaGen® in a parallel randomized double-blind design. An additional Phase 3 trial is planned for initiation in the fourth quarter of 2017.
Is
general: Yes
