Abstract | BACKGROUND: METHODS: EANITIATE is a Danish, open, prospective, multicenter, randomized (1:1), parallel group study in patients with new-onset diabetes following treatment with glucocorticoids (> 20 mg equivalent prednisolone dose/day) with blinded endpoint evaluation (PROBE design). Included patients are randomized to either a Sodium-Glucose-Cotransporter 2 ( SGLT2) inhibitor or neutral protamin Hagedorn ( NPH) insulin and followed for 30 days. Blinded continuous glucose monitoring (CGM) will provide data for the primary endpoint (mean daily blood glucose) and on glucose fluctuations in the two treatment arms. Secondary endpoints are patient related outcomes, hypoglycaemia, means and measures of variation for all values and for time specific glucose values. This is a non-inferiority study with the intent to demonstrate that treatment with empagliflozin is not inferior to treatment with NPH insulin when it comes to glycemic control and side effects. DISCUSSION: This novel approach to management of glucocorticoid-induced hyperglycemia has not been tested before and if SGLT2 inhibition with empaglifozin compared to NPH-insulin is a safe, effective and resource sparing treatment for GIDM, it has the potential to improve the situation for affected patients and have health economic benefits. TRIAL REGISTRATION: www.clinicaltrialsregister.eu no.: 2018-002640-82. Prospectively registered November 20th. 2018. Date of first patient enrolled: June 4th. 2019. This protocol article is based on the EANITATE protocol version 1.3, dated 29. January 2018.
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Authors | Carina Kirstine Klarskov, Helga Holm Schultz, Frederik Persson, Tomas Møller Christensen, Thomas Peter Almdal, Ole Snorgaard, Katrine Bagge Hansen, Ulrik Pedersen-Bjergaard, Peter Lommer Kristensen |
Journal | BMC endocrine disorders
(BMC Endocr Disord)
Vol. 20
Issue 1
Pg. 86
(Jun 15 2020)
ISSN: 1472-6823 [Electronic] England |
PMID | 32539810
(Publication Type: Clinical Trial Protocol, Journal Article)
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Chemical References |
- Benzhydryl Compounds
- Blood Glucose
- Glucocorticoids
- Glucosides
- Hypoglycemic Agents
- Sodium-Glucose Transporter 2 Inhibitors
- Insulin, Isophane
- empagliflozin
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Topics |
- Benzhydryl Compounds
(therapeutic use)
- Blood Glucose
(metabolism)
- Blood Glucose Self-Monitoring
- Diabetes Mellitus, Type 2
(chemically induced, drug therapy, metabolism)
- Equivalence Trials as Topic
- Glucocorticoids
(adverse effects)
- Glucosides
(therapeutic use)
- Glycemic Control
- Humans
- Hypoglycemia
(chemically induced, epidemiology)
- Hypoglycemic Agents
(therapeutic use)
- Insulin, Isophane
(therapeutic use)
- Monitoring, Physiologic
- Multicenter Studies as Topic
- Patient Reported Outcome Measures
- Randomized Controlled Trials as Topic
- Sodium-Glucose Transporter 2 Inhibitors
(therapeutic use)
- Treatment Outcome
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