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)

Abstract

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 HbA1c levels recorded within 3 months prior to U300 (baseline) were included. The primary endpoint was change in HbA1c 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 HbA1c 79 mmol/mol (9.4%)]. After U300 initiation, the mean reduction in HbA1c 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 HbA1c 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.

Insulin Therapy in Adults with Type 1 Diabetes Mellitus: a Narrative Review

“…The 6-month extension of the EDITION 4 trial found comparable glucose control in both treatment groups and similar rates of hypoglycemic events with Gla-100 and Gla-300 [49]. These findings are corroborated by a real-world, observational, retrospective study of patients in the UK which reported that there was no major change in the risk of severe hypoglycemia (1 vs. 2%) with initiation of Gla-300 after 6 months despite a significant decrease in HbA1c of 0.4% (4 mmol/mol) and there was no significant weight gain [50].…”

Real-world data on the use of insulin glargine 300 U/mL in Japanese patients with type 1 diabetes: twelve-month results from a post-marketing surveillance study (X-STAR study)

“…Similar findings were reported in retrospective observational studies such as SPARTA in the UK [14] and REALITY in Canada [18]. In the SPARTA study, the researchers investigated 300 T1DM patients who were switched to Gla-300.…”

“…Although real-world data on the use of Gla-300 in T1DM are limited, the SPARTA trial, a retrospective, observational study in the UK, recently demonstrated that Gla-300 administered to patients with T1DM was associated with a significant reduction in HbA1c and no increase in hypoglycemia [14]. The issue of an unacceptably low insulin titration was also revealed in the trial.…”

Lower risk of severe hypoglycaemia with insulin glargine 300 U/mL versus glargine 100 U/mL in participants with type 1 diabetes: A meta‐analysis of 6‐month phase 3 clinical trials

“…In one retrospective study, the number of nocturnal hypoglycaemic events was significantly reduced within 2 weeks after patients with T1DM were switched from Gla‐100 to Gla‐300 14 . In the SPARTA study, the incidence of SH remained similar before and 6 months after initiation of Gla‐300, despite a significant HbA1c reduction of 0.4% 15 …”

“…14 In the SPARTA study, the incidence of SH remained similar before and 6 months after initiation of Gla-300, despite a significant HbA1c reduction of 0.4%. 15 This post hoc, exploratory analysis has some limitations.…”