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Continuous glucose monitoring in patients with type 2 diabetes treated with glucagon-like peptide-1 receptor agonist dulaglutide in combination with prandial insulin lispro: an AWARD-4 substudy
Örebro University, School of Medical Sciences.ORCID iD: 0000-0003-1025-1682
Department of Biostatistics, Harvard T.H. Chan School of Public Health, Harvard University, Boston, Massachusetts, USA.
Eli Lilly and Company, Indianapolis, USA.
Eli Lilly and Company, Indianapolis, USA.
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2016 (English)In: Diabetes, obesity and metabolism, ISSN 1462-8902, E-ISSN 1463-1326, Vol. 18, no 10, 999-1005 p.Article in journal (Refereed) Published
Abstract [en]

Background: Insulin use with GLP-1 receptor agonists is of interest because of the potential for glucose lowering with reduced insulin dosing versus an insulin-only regimen. The AWARD-4 trial, designed to compare these regimens, included a sub-study using 24-hour continuous glucose monitoring (CGM).

Methods: The AWARD-4 trial randomised 884 conventional insulin regimens-treated patients to dulaglutide 1.5 mg, 0.75 mg and glargine, all in combination with prandial insulin lispro. The CGM sub-study included 144 patients inserted with Medtronic CGMS® iPro™ CGM device to enable 3-day glucose monitoring. CGM sessions were completed at weeks 0, 13, 26, and 52. CGM measures included mean 24-hour glucose, percentage time in target glucose ranges, hyper- and hypoglycaemia, and glucose variability. The primary objective was treatment comparison for percentage time CGM glucose in the 3.9-7.8 mmol/L range after 26 weeks.

Results: At week 26, mean CGM glucose decreased in all treatment groups (change from baseline -2.8 ± 0.3, -2.4 ± 0.3, and -2.5 ± 0.3 mmol/L for dulaglutide 1.5 mg, 0.75 mg, and glargine, respectively); between-group differences were not statistically significant. Treatment groups were similar for percentage time in 3.9-7.8 mmol/L range. Percentage time in 3.9-10.0 mmol/L range was greater for dulaglutide 1.5 mg than glargine (p < 0.05). Dulaglutide and glargine were associated with decreased glucose variability for all CGM variability indices. Overall within-patient SD was significantly reduced with dulaglutide 1.5 mg versus glargine (p < 0.05). At week 52, there were no significant differences between groups for measures of normoglycaemia or near-normoglycaemia and for the overall within-patient SD. Treatment with glargine was associated with greater increases in percentage time glucose was ≤3.9 mmol/L with statistically significant differences between the groups at 52 weeks (p < 0.05).

Conclusions: In combination with prandial lispro, treatment with dulaglutide and glargine resulted in similar proportions of glucose values in the normoglycaemic range, but dulaglutide provided an improved balance between the proportion of values within the near-normoglycaemia range and values within the hypoglycaemic range.

Place, publisher, year, edition, pages
Wiley-Blackwell Publishing Inc., 2016. Vol. 18, no 10, 999-1005 p.
Keyword [en]
Continuous glucose monitoring, dulaglutide, glargine, type 2 diabetes
National Category
Endocrinology and Diabetes
Identifiers
URN: urn:nbn:se:oru:diva-50867DOI: 10.1111/dom.12705ISI: 000383381000006PubMedID: 27279266Scopus ID: 2-s2.0-84978805770OAI: oai:DiVA.org:oru-50867DiVA: diva2:937570
Note

Funding Agency:

Eli Lilly and Company, Indianapolis, IN, USA

Available from: 2016-06-15 Created: 2016-06-15 Last updated: 2017-10-17Bibliographically approved

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CiteExportLink to record
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