A single dose study to evaluate pharmacokinetic and pharmacodynamic equivalence between MK-1293 and insulin glargine in healthy volunteers

Trial Profile

A single dose study to evaluate pharmacokinetic and pharmacodynamic equivalence between MK-1293 and insulin glargine in healthy volunteers

Completed
Phase of Trial: Phase I

Latest Information Update: 05 Aug 2016

At a glance

  • Drugs Insulin glargine (Primary)
  • Indications Type 1 diabetes mellitus; Type 2 diabetes mellitus
  • Focus Pharmacodynamics; Pharmacokinetics
  • Most Recent Events

    • 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
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