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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023972

Enrollment

Registered

2016-09-07

Start date

2016-09-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes

Interventions

CGM is attached after admission. Tofogliflozin 20 mg + Insulin glargine 300 U/ml are used on day 1 and day 2. Then, Ipragliflozin 50 mg + Insulin glargine 300 U/ml are used on day 13 and day 14. CGM i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: type 2 diabetic patients medicated Insulin glargine 300 U/ml for 3 month or longer

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
CGM AOC (70 mg/dL) for glycemic variability (0:00-6:00, 24:00) day2 day14	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactTakeishi Soichi

General Inuyamachuo Hospital Department of Diabetes

souichi19811225@yahoo.co.jp0568-62-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026