Trial Profile
A single dose study to evaluate pharmacokinetic and pharmacodynamic equivalence between MK-1293 and insulin glargine in healthy volunteers
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 07 Feb 2019
Price :
$35
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At a glance
- Drugs Insulin glargine (Primary)
- Indications Type 1 diabetes mellitus; Type 2 diabetes mellitus
- Focus Pharmacodynamics; Pharmacokinetics
- 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.
- 23 Mar 2016 New trial record