An open-label pilot study on preventing glucocorticoid-induced diabetes mellitus with linagliptin

• DOI: 10.1186/s13256-018-1817-6
• Publication Date: 2018-09-29T07:11:26Z
• Authors: Yoshia Miyawaki; Ken-Ei Sada; Yosuke Asano; Keigo Hayashi; Yuriko Yamamura; Sumie Hiramatsu; Keiji Ohashi; Michiko Morishita; Haruki Watanabe; Yoshinori Matsumoto; Katsue Sunahori-W...; Tomoko Kawabata; Jun Wada
• Keywords: Male; Medication Therapy Management; Linagliptin; Pilot Projects; Dipeptidyl peptidase-4 inhibitor; 03 medical and health sciences; Glucocorticoid; 0302 clinical medicine; Japan; Risk Factors; Outcome Assessment, Health Care; Diabetes Mellitus; Humans; Hypoglycemic Agents; Glucocorticoids; Aged; Glycated Hemoglobin; Diabetes; R; Age Factors; 3. Good health; Medicine; Female; Drug Monitoring; Research Article; Glomerular Filtration Rate

Numerous patients develop diabetes in response to glucocorticoid therapy. This study explored the efficacy, safety, and preventive potential of the dipeptidyl peptidase-4 inhibitor, linagliptin (TRADJENTA®), in the development of glucocorticoid-induced diabetes mellitus.From December 2014 to November 2015, we recruited non-diabetic Japanese patients scheduled for treatment with daily prednisolone ≥20 mg. Enrolled patients had at least one of following risk factors for glucocorticoid-induced diabetes mellitus: estimated glomerular filtration rate ≤ 60 mL/minute/1.73 m2; age ≥ 65 years; hemoglobin A1c > 6.0%. A daily dose of 5 mg of linagliptin was administered simultaneously with glucocorticoid therapy. The primary outcome was the development of glucocorticoid-induced diabetes mellitus. Additional orally administered hypoglycemic medications and/or insulin injection therapy was initiated according to the blood glucose level.Four of five patients developed glucocorticoid-induced diabetes mellitus within 1 week of glucocorticoid treatment. For 12 weeks, two of the four patients with glucocorticoid-induced diabetes mellitus required orally administered medications, but no patients required insulin. Blood glucose levels before breakfast and lunch tended to decrease with time; the median glucose levels before breakfast were 93 and 79.5 mg/dL at 1 and 3 weeks, respectively. Two patients experienced mild hypoglycemia around 2 weeks. Glucose levels after lunch remained high throughout all 4 weeks despite decreasing the glucocorticoid dosage.Linagliptin may be insufficient to prevent the development of glucocorticoid-induced diabetes mellitus but has the potential to reduce the requirement for insulin injection therapy. Treatment of glucocorticoid-induced diabetes mellitus was continued for at least 1 month and fasting hypoglycemia in early morning should be monitored after 2 weeks.This trial was registered 02 November 2014 with UMIN Clinical Trials Registry (no. 000015588 ).