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Comparison of Insulin glargine 300 U/ml + SGLT2 inhibitor therapy (Tofogliflozin 20 mg vs. Ipragliflozin 50 mg) using continuous glucose monitoring (CGM): randomised crossover study

Not Applicable
Conditions
type 2 diabetes
Registration Number
JPRN-UMIN000023972
Lead Sponsor
General Inuyamachuo Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
35
Inclusion Criteria

Not provided

Exclusion Criteria

severe renal dysfunction (serum creatinine level over 2.0 mg/dL) judged to be unsuitable for participation for medical reasons

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
CGM AOC (70 mg/dL) for glycemic variability (0:00-6:00, 24:00) day2 day14
Secondary Outcome Measures
NameTimeMethod
M-value (0:00-6:00, 24:00, 8:00-24:00) MAGE MODD ADRR mean glucose level (0:00-6:00, 24:00, 8:00-24:00) SD (0:00-6:00, 24:00, 8:00-24:00) Highest postprandial glucose level within 3 hours after each meal Time from start of meal to the highest postprandial glucose level Differences between preprandial and highest postprandial glucose level for each meal post-breakfast glucose gradient AUC (140 mg/dL) for glycemic variability within 3 h of each meal AUC (0 mg/dL) for glycemic variability in 24 h
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