drugset / Trial / NCT05457933
Efficacy and Safety of Dapagliflozin for the Hospital Management of Patients With Type 2 Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the trial is to examine whether treatment with dapagliflozin plus insulin as compared with insulin alone (basal-bolus insulin) will result in similar blood glucose control and similar rate of complications in patients with diabetes, who are admitted to a hospital in a noncritical setting
Timeline
- Start
- 2022-07-29
- Primary completion
- 2023-01-14
- Completion
- 2023-01-14
Publications
- Background Pasquel FJ, Lansang MC, Dhatariya K, Umpierrez GE. Management of diabetes and hyperglycaemia in the hospital. Lancet Diabetes Endocrinol. 2021 Mar;9(3):174-188. doi: 10.1016/S2213-8587(20)30381-8. Epub 2021 Jan 27.
- Results Damman K, Beusekamp JC, Boorsma EM, Swart HP, Smilde TDJ, Elvan A, van Eck JWM, Heerspink HJL, Voors AA. Randomized, double-blind, placebo-controlled, multicentre pilot study on the effects of empagliflozin on clinical outcomes in patients with acute decompensated heart failure (EMPA-RESPONSE-AHF). Eur J Heart Fail. 2020 Apr;22(4):713-722. doi: 10.1002/ejhf.1713. Epub 2020 Jan 7.
- Kuchay MS, Khatana P, Mishra M, Surendran P, Kaur P, Wasir JS, Gill HK, Singh A, Jain R, Kohli C, Bakshi G, Radhika V, Saheer S, Singh MK, Mishra SK. Dapagliflozin for inpatient hyperglycemia in cardiac surgery patients with type 2 diabetes: randomised controlled trial (Dapa-Hospital trial). Acta Diabetol. 2023 Nov;60(11):1481-1490. doi: 10.1007/s00592-023-02138-4. Epub 2023 Jun 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 10 mg | — |
| Background | Insulin Lispro | Protein / enzyme biologic | — | — |
| Comparator | insulin glargine | Protein / enzyme biologic | — | — |