A Phase III, Multicenter, Randomized, Placebo- and Sitagliptin-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitis Who Have Inadequate Glycemic Control on Diet/Exercise Therapy
Latest Information Update: 12 May 2022
At a glance
- Drugs Omarigliptin (Primary) ; Sitagliptin
- Indications Type 2 diabetes mellitus
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Merck Sharp & Dohme; Merck Sharp & Dohme Corp.
- 27 Aug 2019 Results assessing population pharmacokinetic and pharmacodynamic model by using data from phase I, II and III studies including this study published in the British Journal of Clinical Pharmacology.
- 28 Sep 2015 According to a Merck media release, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved MARIZEV (omarigliptin) 25 mg and 12.5 mg tablets for the treatment of adults with type 2 diabetes. Merck plans to submit omarigliptin for regulatory approval in the United States by the end of 2015.
- 19 Sep 2014 Results presented at the 50th Annual Meeting of the European Association for the Study of Diabetes.