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Diabetes Technol Ther. 2017 Jan;19(1):49-60. doi: 10.1089/dia.2016.0261. Epub 2016 Dec 8.

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).

Author information

1
1 Profil GmbH , Neuss, Germany .
2
2 Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz , Graz, Austria .
3
3 Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach, Germany .
4
4 Boehringer Ingelheim Canada Ltd./Ltee , Burlington, Canada .
5
5 Boehringer Ingelheim Pharma GmbH & Co. KG , Ingelheim, Germany .

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:

Patients (N = 75) with HbA1c ≥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.

KEYWORDS:

Continuous glucose monitoring; HbA1c; Hyperglycemia; Hypoglycemia; Postprandial blood glucose; Type 1 diabetes

PMID:
27929674
DOI:
10.1089/dia.2016.0261
[Indexed for MEDLINE]

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