A Phase III Clinical Trial to Study the Safety and Efficacy of MK-1293 Compared to Lantus in Subjects With Type 1 Diabetes Mellitus
Phase of Trial: Phase III
Latest Information Update: 20 Jul 2017
At a glance
- Drugs Insulin glargine (Primary)
- Indications Type 1 diabetes mellitus
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Merck Sharp & Dohme
- 20 Jul 2017 According to a Merck AG media release, based on the data from this and another phase 3 study (CTP700241298) the U.S. Food and Drug Administration (FDA) has granted tentative approval for LUSDUNA™ Nexvue™ (insulin glargine injection) 100 units/mL for the treatment of type 1 and type 2 diabetes mellitus.
- 10 Jun 2017 Biomarkers information updated
- 05 Aug 2016 According to a Merck media release, the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MK-1293 (Insulin glargine) for the treatment of people with type 1 and type 2 diabetes, data from this study supported the application. The NDA was filed through the 505(b)(2) regulatory pathway.