A Single Dose Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1293 and to Compare Its Pharmacologic Properties to Those of Another Basal Insulin in Subjects With Type I Diabetes
Phase of Trial: Phase I
Latest Information Update: 10 Mar 2017
At a glance
- Drugs Insulin glargine (Primary) ; Insulin aspart
- Indications Type 1 diabetes mellitus
- Focus Pharmacodynamics; Pharmacokinetics
- Sponsors Merck Sharp & Dohme
- 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.
- 22 May 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
- 18 Mar 2015 Planned End Date changed from 1 Jan 2015 to 1 Apr 2015 as reported by ClinicalTrials.gov.