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Sodium-glucose cotransporter 2 inhibitor luseogliflozin improves glycaemic control, assessed by continuous glucose monitoring, even on a low-carbohydrate diet.

Diabetes, obesity & metabolism
July 1, 2016
R Nishimura et al. (6 authors)
LetterRandomized Controlled TrialHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine the effects of combining luseogliflozin with a low-carbohydrate diet (LCD) on 24-hour glucose variability in patients with type 2 diabetes.

Results Summary

Luseogliflozin significantly reduced glucose exposure when combined with either a normal-carbohydrate diet (NCD) or LCD, with no observed hypoglycemia. The LCD alone lowered glucose levels compared to NCD, but luseogliflozin with LCD improved glycemic control similarly to luseogliflozin with NCD.

Population

18 Japanese patients with type 2 diabetes.

Effective Dosage

Luseogliflozin 2.5 mg once daily.

Duration

8 days per treatment phase (crossover design).

Interactions

None mentioned.

Extracted Claims (6)
InterventionDirectionEndpointPopulationDosageImpactClaim #
luseogliflozin with a normal-carbohydrate diet
decrease
glucose exposure in terms of the area under the curve over the course of 24 h
Japanese patients with type 2 diabetes
-555.6 mg/dl·h
significantly reduced
#1
luseogliflozin with a low-carbohydrate diet
decrease
glucose exposure in terms of the area under the curve over the course of 24 h
Japanese patients with type 2 diabetes
-660.7 mg/dl·h
significantly reduced
#2
luseogliflozin with a low-carbohydrate diet
increase
glycaemic control throughout the day
Japanese patients with type 2 diabetes
nearly the same extent as luseogliflozin with the NCD
improved
#3
luseogliflozin with a low-carbohydrate diet
no change
hypoglycaemia
Japanese patients with type 2 diabetes
-
without inducing
#4
luseogliflozin with a normal-carbohydrate diet
no change
hypoglycaemia
Japanese patients with type 2 diabetes
-
without inducing
#5
low-carbohydrate diet
decrease
glucose levels
Japanese patients with type 2 diabetes
-
were lower
#6
Abstract

This randomized, double-blind, placebo-controlled, crossover study was the first to determine the effects of luseogliflozin in combination with a low-carbohydrate diet (LCD) on 24-h glucose variability, assessed by continuous glucose monitoring (CGM). A total of 18 Japanese patients with type 2 diabetes were randomized into two groups, in which patients first received luseogliflozin 2.5 mg once daily then placebo for 8 days each, or vice versa. Patients took luseogliflozin or placebo with a normal-carbohydrate diet (NCD) on day 7 and with the LCD on day 8. CGM was performed on both days. Luseogliflozin significantly reduced glucose exposure in terms of the area under the curve over the course of 24 h when administered with the NCD (difference vs placebo: -555.6 mg/dl·h [1 mg/dl = 0.0556 mmol/l]; p < 0.001) or with the LCD (-660.7 mg/dl·h; p < 0.001). No hypoglycaemia was observed over 24 h with either diet. Although glucose levels were lower with the LCD than with the NCD in the placebo treatment period, luseogliflozin with the LCD improved glycaemic control throughout the day to nearly the same extent as luseogliflozin with the NCD, without inducing hypoglycaemia.

Medical Subject Headings (MeSH)
Administration, OralBlood GlucoseCross-Over StudiesDiabetes Mellitus, Type 2Diet, Carbohydrate-RestrictedDouble-Blind MethodFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsMaleMiddle AgedSodium-Glucose Transporter 2Sodium-Glucose Transporter 2 InhibitorsSorbitolTreatment Outcome
Study Links
Quality Scores
Safety90
Efficacy85/10
Quality88/10
Citation Metrics
Total Citations21
Citations/Year2.3
Relative Citation Ratio0.89
NIH Percentile45.9%
Research Impact Scores
APT Score0.75
Weight Score1.98
Normalized Score0.88
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