Sustained glycaemic control and less nocturnal hypoglycaemia with insulin glargine 300 U/mL compared with glargine 100 U/mL in Japanese adults with type 1 diabetes (EDITION JP 1 randomised 12-month trial including 6-month extension)
| Autor: | Takahisa Hirose, Masayoshi Koyama, Geremia B. Bolli, X. Cheng, Mariko Sumi, Matthew C. Riddle, Munehide Matsuhisa |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Blood Glucose
Male Time Factors Endocrinology Diabetes and Metabolism medicine.medical_treatment Phases of clinical research 030204 cardiovascular system & hematology 0302 clinical medicine Endocrinology Japan Glycaemic control Insulin Hemoglobin A General Medicine Middle Aged Insulin Long-Acting Diabetes and Metabolism Type 1 diabetes Nocturnal hypoglycaemia lipids (amino acids peptides and proteins) Female hormones hormone substitutes and hormone antagonists medicine.drug Type 1 Adult medicine.medical_specialty Insulin glargine Hypoglycaemia Blood Glucose Self-Monitoring Diabetes Mellitus Type 1 Follow-Up Studies Hemoglobin A Glycosylated Humans Hypoglycemia Hypoglycemic Agents Insulin Glargine Internal Medicine Glycosylated 030209 endocrinology & metabolism Body weight 03 medical and health sciences Diabetes mellitus Internal medicine medicine Diabetes Mellitus Long-Acting cardiovascular diseases Adverse effect Glycated Hemoglobin business.industry nutritional and metabolic diseases medicine.disease Surgery business |
| Popis: | To evaluate the efficacy and safety of insulin glargine 300U/mL (Gla-300) versus glargine 100U/mL (Gla-100) in adults with type 1 diabetes in Japan over 12months.EDITION JP 1 was a multicentre, randomised, open-label phase 3 study. Following a 6-month on-treatment period, participants continued to receive Gla-300 or Gla-100 once daily, plus mealtime insulin, over a 6-month open-label extension phase. HbA1c, hypoglycaemia, body weight and adverse events were assessed.Overall, 114/122 (93%) and 114/121 (94%) of participants in the Gla-300 and Gla-100 group, respectively, completed the 6-month extension phase. Glycaemic control was sustained in both groups up to month 12 (mean HbA1c: Gla-300, 7.9% [62mmol/mol]; Gla-100, 7.8% [62mmol/mol]). Annualised rates of hypoglycaemia were lower with Gla-300 versus Gla-100; significantly for nocturnal confirmed (3.0mmol/L [54mg/dL]) or severe hypoglycaemia (2.39 and 3.85 events per participant-year; rate ratio: 0.62 [0.39-0.97]). No between-treatment differences in mean body weight change or adverse events were observed.Over 12months' treatment, participants with type 1 diabetes receiving Gla-300 achieved sustained glycaemic control and experienced less nocturnal hypoglycaemia that was confirmed (3.0mmol/L [54mg/dL]) or severe compared with Gla-100, supporting the 6-month results. |
| Databáze: | OpenAIRE |
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