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Cardiovasc Diabetol. 2015 Jan 30;14:11. doi: 10.1186/s12933-014-0169-9.

Effect of empagliflozin monotherapy on postprandial glucose and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, 4-week study.

Author information

1
Jikei University School of Medicine, Tokyo, Japan. rimei.nishimura@gmail.com.
2
Nippon Boehringer Ingelheim Co. Ltd, Osaki 2-1-1, ThinkPark Tower, Tokyo, 141-6017, Japan. yuko.tanaka@boehringer-ingelheim.com.
3
Nippon Boehringer Ingelheim Co. Ltd, Osaki 2-1-1, ThinkPark Tower, Tokyo, 141-6017, Japan. kazuki.koiwai@boehringer-ingelheim.com.
4
EPS Corporation, Tokyo, Japan. kohei.inoue.ext@boehringer-ingelheim.com.
5
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. thomas.hach@boehringer-ingelheim.com.
6
Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA. afshin.salsali@boehringer-ingelheim.com.
7
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. soeren.lund@boehringer-ingelheim.com.
8
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. Uli.Broedl@boehringer-ingelheim.com.

Abstract

BACKGROUND:

This study evaluated the effect of empagliflozin on postprandial glucose (PPG) and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus (T2DM).

METHODS:

Patients (N = 60; baseline mean [SD] HbA1c 7.91 [0.80]%; body mass index 24.3 [3.2] kg/m(2)) were randomized to receive empagliflozin 10 mg (n = 20), empagliflozin 25 mg (n = 19) or placebo (n = 21) once daily as monotherapy for 28 days. A meal tolerance test and continuous glucose monitoring (CGM) for 24 hours were performed at baseline and on days 1 and 28. The primary endpoint was change from baseline in area under the glucose concentration-time curve 3 hours after breakfast (AUC1-4h for PPG) at day 28.

RESULTS:

Adjusted mean (95%) differences versus placebo in changes from baseline in AUC1-4h for PPG at day 1 were -97.1 (-126.5, -67.8) mg · h/dl with empagliflozin 10 mg and -91.6 (-120.4, -62.8) mg · h/dl with empagliflozin 25 mg (both p < 0.001 versus placebo) and at day 28 were -85.5 (-126.0, -45.0) mg · h/dl with empagliflozin 10 mg and -104.9 (-144.8, -65.0) mg · h/dl with empagliflozin 25 mg (both p < 0.001 versus placebo). Adjusted mean (95% CI) differences versus placebo in change from baseline in 24-hour mean glucose (CGM) at day 1 were -20.8 (-27.0, -14.7) mg/dl with empagliflozin 10 mg and -23.9 (-30.0, -17.9) mg/dl with empagliflozin 25 mg (both p < 0.001 versus placebo) and at day 28 were -24.5 (-35.4, -13.6) mg/dl with empagliflozin 10 mg and -31.7 (-42.5,-20.9) mg/dl with empagliflozin 25 mg (both p < 0.001 versus placebo). Changes from baseline in mean amplitude of glucose excursions (MAGE; CGM) were not significantly different with either empagliflozin dose versus placebo at either timepoint. Curves of mean glucose (CGM) did not change between baseline and day 1 or 28 with placebo, but shifted downward with empagliflozin. Percentage of time with glucose ≥70 to <180 mg/dl increased from 52.0% at baseline to 77.0% at day 28 with empagliflozin 10 mg and from 55.0% to 81.1% with empagliflozin 25 mg, without increasing time spent with hypoglycemia.

CONCLUSION:

Empagliflozin for 28 days reduced PPG from the first day and improved daily blood glucose control in Japanese patients with T2DM.

TRIAL REGISTRATION:

Clinicaltrials.gov NCT01947855.

PMID:
25633683
PMCID:
PMC4339254
DOI:
10.1186/s12933-014-0169-9
[Indexed for MEDLINE]
Free PMC Article

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