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An open-label pilot study on preventing glucocorticoid-induced diabetes mellitus with linagliptin
Yoshia Miyawaki1, Ken-Ei Sada2, Yosuke Asano1
1Department of Nephrology, Rheumatology, Endocrinology and Metabolism, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Kitaku, Okayama City, 700-8558, Japan.
Background:
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.
Methods:
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.
Results:
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.
Conclusions:
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.
Trial Registration:
This trial was registered 02 November 2014 with UMIN Clinical Trials Registry (no. 000015588 ).
Insights
Linagliptin (TRADJENTA®) may not fully prevent glucocorticoid-induced diabetes mellitus but can reduce insulin needs. Close monitoring for hypoglycemia is recommended during treatment.
Area of Science:
- Endocrinology
- Pharmacology
Background:
- Glucocorticoid therapy frequently causes diabetes mellitus.
- Linagliptin, a dipeptidyl peptidase-4 inhibitor, was investigated for its role in preventing and managing glucocorticoid-induced diabetes mellitus.
Purpose of the Study:
- To evaluate the efficacy and safety of linagliptin in preventing glucocorticoid-induced diabetes mellitus.
- To assess linagliptin's potential to reduce the need for additional hypoglycemic medications.
Main Methods:
- A study involving non-diabetic Japanese patients receiving daily prednisolone (≥20 mg) and linagliptin (5 mg).
- Patients had risk factors for glucocorticoid-induced diabetes mellitus, including impaired kidney function, advanced age, or elevated HbA1c.
- Primary outcome was the development of glucocorticoid-induced diabetes mellitus, with interventions based on blood glucose levels.
Main Results:
- Four out of five patients developed glucocorticoid-induced diabetes mellitus within one week of glucocorticoid treatment.
- Two patients required oral hypoglycemic agents, but none needed insulin therapy.
- Blood glucose levels decreased over time, though post-lunch glucose remained elevated; mild hypoglycemia was observed in two patients.
Conclusions:
- Linagliptin appears insufficient to prevent glucocorticoid-induced diabetes mellitus but may decrease the need for insulin.
- Treatment for glucocorticoid-induced diabetes mellitus should continue for at least one month.
- Monitoring for early morning fasting hypoglycemia is crucial after two weeks of treatment.
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