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1 sty 2024 · This document provides guidance on clinical development programmes intended to support the registration of new medicinal products for the treatment of diabetes mellitus. It also addresses the development of products to delay in onset or prevention of diabetes mellitus or preservation of beta-cell function in patients with diabetes.
- Guideline on clinical inviestigation of medicinal products in the ...
In dose-ranging studies, at least 3 dosages should be...
- Guideline on clinical investigation of medicinal products in the ...
622 Therapeutic confirmatory studies should assess the...
- Guideline on clinical inviestigation of medicinal products in the ...
In dose-ranging studies, at least 3 dosages should be studied with a total treatment phase of at least 8 weeks. Glucose based metrics should be the primary evaluation criterion in dose-ranging studies of 8-12 weeks duration. Serum fructosamine can also be used as an endpoint in short-term studies.
622 Therapeutic confirmatory studies should assess the safety and efficacy of the insulin preparation in 623 type 1 and type 2 diabetes. Patients should be treated to glycaemic target taking into account limiting 624 adverse effects, particularly hypoglycaemia.
4 maj 2024 · The European Medicines Agency (EMA)’s revised guideline on the clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus took effect on 1 January 2024, replacing the previous guideline from 2012 [1, 2].
The European Medicines Agency (EMA)’s revised guide-line on the clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus took efect on 1 January 2024, replacing the previous guideline from 2012 [1, 2].
New guideline of the European Medicines Agency (EMA) on the clinical investigation of medicinal products in the treatment and prevention of diabetes mellitus. Diabetologia. 2024 Jul;67 (7):1159-1162. doi: 10.1007/s00125-024-06162-z. Epub 2024 May 4. Authors.
4 maj 2024 · Results 764 trials including 421 346 patients proved eligible. All results refer to the addition of SGLT-2 inhibitors and GLP-1 receptor agonists to existing diabetes treatment.
