A Retrospective Observational Study to Assess the Effectiveness of Insulin Glargine 300U/mL in Treating Patients With Type 1 Diabetes in the United Kingdom

Presentation Number: MON-173-LB
Date of Presentation: March 19, 2018, 2018

Terence Pang, PhD FRCP Edin1, Stephen C. Bain, MA, MD, FCRP2, Neil Black, MD, FCRP3, James Boyle, MD, FRCP4, Jackie Elliott, PhD, MRCP5, Adele Holcombe, BSc6, Keni C.S. Lee, PhD7, Ciara Mulligan, PhD, FRCP8, Luke Saunders, PhD, MSc9, Ahmed Youssef, PhD FRCP10, Michael Baxter, PhD, FRCP7.
1The Dudley Group NHS Foundation Trust, Russells Hall Hospital, Dudley, United Kingdom, 2Institute of Life Science, Swansea University Medical School, Swansea, United Kingdom, 3Altnagelvin Hospital, Western Health & Social Care Trust, Derry, United Kingdom, 4Glasgow Royal Infirmary, Glasgow, United Kingdom, 5Diabetes and Endocrine Department, Sheffield Teaching Hospitals, Sheffield, United Kingdom, 6North East Essex Diabetes Service, Suffolk GP Federation, Essex, United Kingdom, 7Sanofi, Guildford, United Kingdom, 8Ulster Hospital, SE Trust, Belfast, United Kingdom, 9pH Associates, Marlow, United Kingdom, 10Ashford and St Peter’s Hospitals NHS Foundation Trust, Chertsey, United Kingdom.

Abstract

Insulin glargine 300U/mL (Gla-300) is a second generation once-daily basal insulin (BI) analog. The aim of SPARTA was to describe demographics, treatment patterns, hypoglycemia occurrence, and clinical effectiveness of Gla-300 in a cohort of UK patients (pts) with type 1 diabetes (T1D). Pts with T1D (≥18 and <75 years) prescribed Gla-300 ≥6 months before data collection and with glycated hemoglobin (HbA1c) levels recorded within 3 months prior to Gla-300 treatment initiation (defined as baseline) were included. The primary study endpoint was change in HbA1c levels from baseline to Month 6 after the initiation of Gla-300. Other endpoints included differences between the number of hypoglycemic and diabetic ketoacidosis (DKA) episodes and the distribution and severity of episodes 6 months prior to and following initiation of Gla-300; the total daily BI dose on the most recent insulin therapy prior to initiation of Gla-300 and the total daily dose of BI following 6 months on Gla-300; and the description of reasons for discontinuing previous diabetes therapy prior to initiation of Gla-300. Analyses involving a within-pt change from baseline reported only those data available at both time points.In total, 299 pts with T1D were recruited with a baseline mean age of 42.2 (standard deviation 14.0) years. 173 pts had HbA1c levels recorded at baseline and 6 months: mean (SD) baseline was 78.0 (18.4) mmol/mol and mean body mass index was 28.3 (6.7) kg/m2 (n=161). The mean difference in HbA1c from baseline to Month 6 after initiation of Gla-300 was -4.4 mmol/mol (95% confidence interval [CI]: −6.3, −2.5; p<0.001). The total daily BI dose following Gla-300 initiation increased to Month 6 (0.69U [95% CI: 0.13, 1.26; p<0.05]) but was not significantly different to the prior BI therapy dose. Recorded reasons for discontinuing previous diabetes therapy prior to Gla-300 initiation (n=250) included lack of efficacy (58% [n=145]), hypoglycemia concerns (21% [n=53]), difficulty with dosing (10% [n=26]), difficulty with device (1% [n=3]), adverse events (<1% [n=2]), and ‘unknown’ (8% [n=21]). In the 6 months prior to Gla-300 initiation, 23/299 (8%) and 4/299 (1%) pts experienced hypoglycemia or episodes of DKA, respectively. The total number of hypoglycemic and DKA episodes reported by pts during the 6 months post-initiation of Gla-300 were 31/299 (10%) and 7/299 (2%), respectively. Prior to Gla-300, 17 (6%) pts reported mild/moderate and 6 (2%) experienced severe hypoglycemic episodes; post-initiation of Gla-300, 27 (9%) reported mild/moderate and 4 (1%) severe hypoglycemic episodes. From real-word experience, Gla-300 use in pts with T1D is associated with clinically and statistically significant HbA1c improvements, without significant changes in BI dose and no change in reported DKA or severe hypoglycemia events.*Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.

Disclosures

  T. Pang: Advisory Board Member; Spouse; Novo Nordisk. Speaker; Spouse; Sanofi, Janssens, Lilly. Other; Self; Sanofi, Lilly, Novo Nordisk, Janssens. Other; Spouse; Sanofi. S.C. Bain: Advisory Board Member; Self; Sanofi, Novo Nordisk, Boehringer Ingelheim, AstraZeneca. Speaker; Self; Sanofi, Novo Nordisk, Boehringer Ingelheim, AstraZeneca. Other; Self; Sanofi, Novo Nordisk, AstraZeneca. N. Black: None. J. Boyle: Advisory Board Member; Self; Sanofi, Novo Nordisk. Research Investigator; Self; Sanofi, Boehringer Ingelheim, Lexicon. Speaker; Self; Napp, AstraZeneca. J. Elliott: None. A. Holcombe: None. K.C. Lee: Employee; Self; Sanofi. C. Mulligan: Advisory Board Member; Self; Novo Nordisk. Speaker; Self; Sanofi, Eli Lilly, Boehringer Ingelheim. Other; Self; Sanofi. L. Saunders: None. A. Youssef: Consulting Fee; Self; Sanofi. Consulting Fee; Spouse; Sanofi. M. Baxter: Employee; Self; Sanofi.