drugset / Trial / NCT02548585
A Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A Phase 1/2, multiple dose study with 6 cohorts of ascending doses designed to evaluate the efficacy, safety and pharmacokinetics (PK) of MEDI0382 in participants with Type 2 Diabetes Mellitus (T2DM).
Timeline
- Start
- 2015-12-09
- Primary completion
- 2017-02-24
- Completion
- 2017-02-24
Publications
- Bosch R, Petrone M, Arends R, Vicini P, Sijbrands EJG, Hoefman S, Snelder N. Characterisation of cotadutide's dual GLP-1/glucagon receptor agonistic effects on glycaemic control using an in vivo human glucose regulation quantitative systems pharmacology model. Br J Pharmacol. 2024 Jun;181(12):1874-1885. doi: 10.1111/bph.16336. Epub 2024 Feb 25.
- Ambery P, Parker VE, Stumvoll M, Posch MG, Heise T, Plum-Moerschel L, Tsai LF, Robertson D, Jain M, Petrone M, Rondinone C, Hirshberg B, Jermutus L. MEDI0382, a GLP-1 and glucagon receptor dual agonist, in obese or overweight patients with type 2 diabetes: a randomised, controlled, double-blind, ascending dose and phase 2a study. Lancet. 2018 Jun 30;391(10140):2607-2618. doi: 10.1016/S0140-6736(18)30726-8. Epub 2018 Jun 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cotadutide | Peptide | 100 ug | Subcutaneous |
| Subject | Cotadutide | Peptide | 150 ug | Subcutaneous |
| Subject | Cotadutide | Peptide | 200 ug | Subcutaneous |
| Subject | Cotadutide | Peptide | 300 ug | Subcutaneous |