Glucose exposure and variability with empagliflozin as adjunct to insulin in patients with type 1 diabetes: continuous glucose monitoring data from a 4-week, randomized, placebo-controlled trial (EASE-1)

Famulla, Susanne; Pieber, Thomas R.; Eilbracht, Jens; Neubacher, Dietmar; Soleymanlou, Nima; Woerle, Hans J.; Broedl, Uli C.; Kaspers, Stefan

doi:10.1089/dia.2016.0261

Cited by 54Diabetes Management and ResearchDiabetes Treatment and ManagementDiabetes Management and Education

Glucose exposure and variability with empagliflozin as adjunct to insulin in patients with type 1 diabetes: continuous glucose monitoring data from a 4-week, randomized, placebo-controlled trial (EASE-1)

Famulla, Susanne, Pieber, Thomas R., Eilbracht, Jens, Neubacher, Dietmar, Soleymanlou, Nima, Woerle, Hans J., Broedl, Uli C., Kaspers, Stefan·2017·Diabetes Technology & Therapeutics

DOI 10.1089/dia.2016.0261

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Abstract

BACKGROUND: We evaluated the effect of empagliflozin as adjunct to insulin on 24-h glucose exposure and variability in patients with type 1 diabetes. METHODS: ≥7.5% to ≤10.5% were randomized to receive empagliflozin 2.5 mg, empagliflozin 10 mg, empagliflozin 25 mg, or placebo once daily as adjunct to insulin for 4 weeks. Insulin dose was to be kept as stable as possible during week 1 of treatment and was freely adjustable thereafter. Markers of glucose exposure and variability were assessed from 7-day blinded continuous glucose monitoring intervals. This study is completed ( ClinicalTrials.gov NCT01969747). RESULTS: Empagliflozin reduced hourly mean glucose area under the median curve over 24 h versus placebo within week 1 (adjusted mean differences: -12.2 mg/dL·h [95% confidence interval -23.9 to -0.5], -30.2 mg/dL·h [-42.2 to -18.2], and -33.0 mg/dL·h [-44.8 to -21.1] with empagliflozin 2.5, 10, and 25 mg, respectively; all P < 0.05) and increased time in glucose target range (>70 to ≤180 mg/dL). Results were sustained to week 4 with empagliflozin 25 mg. All empagliflozin doses significantly reduced glucose variability (interquartile range and mean amplitude of glucose excursions) versus placebo at weeks 1 and 4. Except for small increases in hours per day with glucose ≤70 mg/dL during the stable insulin period, empagliflozin did not increase time in hypoglycemia compared with placebo. CONCLUSIONS: In patients with type 1 diabetes, empagliflozin as adjunct to insulin decreased glucose exposure and variability and increased time in glucose target range.

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In type 2 diabetes, there is generally less glycemic variability and hypoglycemia than in type 1 diabetes.
“In type 2 diabetes, there is generally less glycemic variability and hypoglycemia than in type 1 diabetes (46).”
From Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range (2019) · cites this paper as [46]

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Sodium-Glucose Cotransporter 2 Inhibitors for People with Type 1 Diabetes
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Az SGLT-2-gátló és a duális SGLT-2/SGLT-1-gátló készítmények potenciális helye az 1-es típusú diabetes terápiájában
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Sodium/glucose cotransporter 2 inhibitors for the treatment of type 1 diabetes: what are the latest developments?
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Diurnal Glycemic Patterns during an 8-Week Open-Label Proof-of-Concept Trial of Empagliflozin in Type 1 Diabetes
Perkins, B. A., Cherney, D. Z. I., Soleymanlou, N., Lee, J. A., Partridge, H., Menezes, H. T., Zinman, B., Mazze, R., Fagan, N. M., Kaspers, S., et al. (2015) · PLoS ONE · doi:10.1371/journal.pone.0141085 · Cited by 32 · see citing works
Self-citation
Empagliflozin as adjunct to insulin in patients with type 1 diabetes: a 4‐week, randomized, placebo‐controlled trial ( EASE ‐1)
Pieber, T. R., Famulla, S., Eilbracht, J., Cescutti, J., Soleymanlou, N., Johansen, O. E., Woerle, H. J., Broedl, U. C., & Kaspers, S. (2015) · Diabetes Obesity and Metabolism · doi:10.1111/dom.12494 · Cited by 167 · see citing works
Self-citation
Effects of empagliflozin on glycemic variability in non-obese adults with type 1 diabetes: a randomized pilot trial.docx
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Glucose Variables in Type 1 Diabetes Studies With Dapagliflozin: Pooled Analysis of Continuous Glucose Monitoring Data From DEPICT-1 and -2
Mathieu, C., Dandona, P., Phillip, M., Oron, T., Lind, M., Hansen, L., THOREN, F. A., Xu, J., Langkilde, A. M., & on behalf of the DEPICT-1 and DEPICT-2 Investigators (2019) · Diabetes Care · doi:10.2337/dc18-1983 · Cited by 48 · see citing works
Dapagliflozin as an Adjunct to Insulin Improves Time-in-Range and Glycemic Variability versus Acarbose in Adults With Type 1 Diabetes: A Randomized Crossover Trial
Wu, Y., Chen, Y., Chen, X. H., Wang, J., Li, Q., Deng, Z., He, Y., Ma, Z., Yang, R., Zeng, Q., et al. (2026) · Endocrine Practice · doi:10.1016/j.eprac.2026.05.030

Authors: Famulla, S., Pieber, T. R., Eilbracht, J., Neubacher, D., Soleymanlou, N., Woerle, H. J., Broedl, U. C., & Kaspers, S.
Affiliations: Profil GmbH
Medical University of Graz (AT)
Boehringer Ingelheim (Germany) (DE)
Boehringer Ingelheim (Canada) (CA)
Corresponding author: Famulla, Susanne
ORCID: Pieber, Thomas R.
Woerle, Hans J.
Broedl, Uli C.
Venue: Diabetes Technology & Therapeutics
Publisher: SAGE Publications
Published: 2017-01
Volume: 19
Issue: 1
Pages: 49-60
ISSN: 1520-9156 (ISSN-L)
1557-8593
DOI: 10.1089/dia.2016.0261
OpenAlex: W2560280991
Cited by: 53
References: 22
Citations by year: 2024: 1 · 2023: 4 · 2022: 2 · 2021: 8 · 2020: 13 · 2019: 11 · 2018: 11 · 2017: 3
FWCI: 8.35
Type: journal article
Language: en
Open access: closed
Licence: journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
Locations: Diabetes Technology & Therapeutics (publishedVersion)
PubMed (publishedVersion)
Funders: Eli Lilly and Company
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Keywords: empagliflozin, type 1 diabetes, insulin, glucose exposure, glycemic variability, continuous glucose monitoring, SGLT2 inhibitors, time in range, hypoglycemia
MeSH terms: Adult, Benzhydryl Compounds, Blood Glucose, Diabetes Mellitus, Type 1, Double-Blind Method, Drug Therapy, Combination, Female, Glucosides, Humans, Hypoglycemic Agents, Insulin, Male, Middle Aged, Blood Glucose Self-Monitoring, Treatment Outcome

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Glucose exposure and variability with empagliflozin as adjunct to insulin in patients with type 1 diabetes: continuous glucose monitoring data from a 4-week, randomized, placebo-controlled trial (EASE-1)

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