A multicentre, UK, retrospective, observational study to assess the effectiveness of insulin glargine 300 units/ml in treating people with Type 1 diabetes mellitus in routine clinical practice (SPARTA).

Autor: Pang T; Dudley Group NHS Foundation Trust, Russells Hall Hospital, Dudley., Bain SC; Institute of Life Science, Swansea University Medical School, Swansea., Black RNA; Department of Endocrinology and Diabetes, Altnagelvin Hospital, Derry., Boyle JG; Glasgow Royal Infirmary, School of Medicine, University of Glasgow, Glasgow., Elliott J; Diabetes and Endocrine Department, Sheffield Teaching Hospitals, Sheffield., Holcombe A; North East Essex Diabetes Service, Suffolk GP Federation, Colchester., Lee KCS; Sanofi, Guildford., Mulligan C; Ulster Hospital, SE Trust, Belfast., Saunders L; pH Associates, Marlow., Yousseif A; Diabetes and Endocrine Department, Royal Free London NHS Foundation Trust, London, UK., Baxter M; Sanofi, Guildford.
Jazyk: angličtina
Zdroj: Diabetic medicine : a journal of the British Diabetic Association [Diabet Med] 2019 Jan; Vol. 36 (1), pp. 110-119. Date of Electronic Publication: 2018 Nov 16.
DOI: 10.1111/dme.13847
Abstrakt: Aim: To conduct an open-label study to provide UK real-world evidence regarding the use of insulin glargine 300 units/ml (U300) in people with Type 1 diabetes mellitus.
Methods: People with Type 1 diabetes who had been prescribed U300 ≥6 months before data collection and had HbA 1c levels recorded within 3 months prior to U300 (baseline) were included. The primary endpoint was change in HbA 1c from baseline to month 6 after U300 initiation. Other endpoints included number of documented hypoglycaemic and diabetic ketoacidosis episodes, and change in daily basal insulin dose.
Results: A total of 298 people with Type 1 diabetes were included [mean age 42.1 years, mean HbA 1c 79 mmol/mol (9.4%)]. After U300 initiation, the mean reduction in HbA 1c from baseline to month 6 was -4 mmol/mol (-0.4%; P<0.001; n=188). The total daily basal insulin dose at 6 months was 1.3 units higher than at the time of U300 initiation (P<0.001; n=275) but was not significantly different from the prior basal insulin dose. There was no clinically significant difference in weight between baseline and month 6 [mean difference +0.7 kg, 95% CI -0.1, 1.5; P=0.084; n=115). During the 6 months before and after U300 initiation, severe hypoglycaemic episodes were documented for 6/298 and 4/298 participants. Diabetic ketoacidosis episodes requiring Accident and Emergency department visits or hospitalization were documented for 4/298 and 6/298 participants, before and after U300 initiation, respectively.
Conclusions: In people with Type 1 diabetes, a change in basal insulin to U300 was associated with clinically and statistically significant HbA 1c improvements, without significant changes in basal insulin dose and weight. Documented severe hypoglycaemia episodes and diabetic ketoacidosis requiring Accident and Emergency department visits or hospitalization were low and similar before and after U300 initiation.
(© 2018 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.)
Databáze: MEDLINE
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