Trial Profile
An Open-label, Randomized, Multi-center, Parallel Group Clinical Trial Comparing the Efficacy and Safety of Mylan's Insulin Glargine With Lantus in Type 2 Diabetes Mellitus Patients
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 06 Nov 2021
Price :
$35
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At a glance
- Drugs Insulin glargine (Primary)
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Acronyms INSTRIDE 2
- Sponsors Mylan
- 11 Jun 2020 According to a Mylan media release, the approval for Semglee was based on a comprehensive analytical, preclinical and clinical program (including the INSTRIDE studies) which confirmed the PK/PD, efficacy, safety and immunogenicity of Semglee in comparison to Lantus in patients with type 1 and type 2 diabetes.
- 11 Jun 2020 According to a Mylan media release, the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Semglee (insulin glargine injection), in vial and pre-filled pen presentations, to control high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes.
- 08 Dec 2017 Results comparing immunogenicity between MYL-1501D and insulin glargine, presented at the 2017 Congress of the International Diabetes Federation.