Clinical study of repaglinide efficacy and safety in type 2 diabetes mellitus patients with blood glucose levels inadequately controlled by sitagliptin
| Autor: | Toshiaki Hanafusa, Shigeru Kageyama, Kohei Kaku, Nigishi Hotta, Katsuhisa Ioriya, Ryuzo Kawamori |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Adult
Blood Glucose Male medicine.medical_specialty Endocrinology Diabetes and Metabolism 030209 endocrinology & metabolism 030204 cardiovascular system & hematology Pharmacology Hypoglycemia Sitagliptin Phosphate 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Piperidines Diabetes mellitus Internal medicine Internal Medicine Medicine Sitagliptin Humans Hypoglycemic Agents Adverse effect Aged Glycated Hemoglobin business.industry Type 2 Diabetes Mellitus General Medicine Articles Middle Aged Repaglinide medicine.disease Clinical Trial Clinical Science and Care Combination drug therapy chemistry Diabetes Mellitus Type 2 Female Glycated hemoglobin Carbamates business medicine.drug |
| Zdroj: | Journal of Diabetes Investigation |
| ISSN: | 2040-1124 2040-1116 |
| Popis: | Aims/Introduction The aim of the present study was to evaluate the long-term efficacy and safety of adding repaglinide in patients with type 2 diabetes mellitus whose blood glucose levels were not sufficiently controlled by treatment with a dipeptidyl peptidase-4 inhibitor, sitagliptin, in addition to diet and exercise therapies. Materials and Methods This was a multicenter, uncontrolled, dose-titration study with a treatment period of 52 weeks. The primary end-point was the change in glycated hemoglobin levels from baseline. Results The glycated hemoglobin level was 7.43 ± 0.57% (mean ± standard deviation) at baseline, and decreased to 6.93 ± 0.91% at the end of the study. The mean changes in glycated hemoglobin levels at 4 weeks and at the end of the study were −0.44 ± 0.28% and −0.50 ± 0.82%, respectively. The glycated hemoglobin-lowering effect was maintained for 52 weeks. The rate of adverse events was 86.0% (86/100), and there were 352 adverse events. The rate of adverse drug reactions was 21.0% (21/100). Hypoglycemia was reported in 5.0% (5/100) of patients, but there was no incidence of ‘major hypoglycemia’. Conclusions Combination therapy with repaglinide and sitagliptin was considered effective for a long term without clinical safety problems in patients with type 2 diabetes mellitus. |
| Databáze: | OpenAIRE |
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