Comparison of effect characteristics between Rapid-Acting Insulin Analogues in hospitalized patients with type 1 and type 2 diabetes.

Comparison of effect characteristics between Rapid-Acting Insulin Analogues in hospitalized patients with type 1 and type 2 diabetes. - Comparison of effect characteristics between Rapid-Acting Insulin Analogues in hospitalized patients with type 1 and type 2 diabetes.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000042039

Enrollment

Registered

2020-10-07

Start date

2020-10-12

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 1 and type 2 diabetes

Interventions

This study is an open-label, crossover study. By allocation, Fiasp or URLi will be administered before each meal on the 1st and 2nd days, and Humalog will be administered on the 3rd day. Blood is coll

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For patients who meet all of the following criteria 1) Age: Type 1 and type 2 diabetic patients whose age at the time of consent is 20 to 75 years old 2) Gender: No matter 3) Patients admitted to our hospital 4) Patients who have been hospitalized for more than 1 week and whose blood glucose level is stable and reproducible using rapid-acting insulin 3 times a day

Exclusion criteria

Exclusion criteria: Patients who fall under any of the following will not be included in this study. 1) Patients with severe ketosis, diabetic coma or precoma 2) Patients with severe infections, before and after surgery, and with serious external injury 3) Patients with severe renal dysfunction or end-stage renal disease on dialysis 4) Patients judged by the attending physician to be inappropriate for this study due to other reasons

Design outcomes

Primary

Measure	Time frame
To compare the effects between Humalog and URLi, Fiasp by measuring blood glucose 10 times a day and calculating the AUC (trapezoidal method) for the increase in blood glucose from before breakfast.	—

Secondary

Measure	Time frame
(1) Daily blood glucose fluctuation by AUC (trapezoidal method) of each insulin by CGM (Continuous Blood Glucose Monitoring Device) (2) Evaluation of endogenous insulin secretion by blood sampling of C-peptide 10 times a day (conducted only for type 2 diabetic patients) (3) Number of occurrences of hypoglycemia (4) Changes in mean blood glucose level on CGM (5) Changes in blood glucose SDlog on CGM (6) Comparison of the effects between URLi and Fiasp by measuring blood glucose 10 times a day and calculating the AUC (trapezoidal method) for the increase in blood glucose from before breakfast. (7) Comparison of the effects between URLi and Fiasp by CGM and calculating the AUC (trapezoidal method) for the increase in blood glucose from before breakfast.	—

Measure

Time frame

(1) Daily blood glucose fluctuation by AUC (trapezoidal method) of each insulin by CGM (Continuous Blood Glucose Monitoring Device) (2) Evaluation of endogenous insulin secretion by blood sampling of C-peptide 10 times a day (conducted only for type 2 diabetic patients) (3) Number of occurrences of hypoglycemia (4) Changes in mean blood glucose level on CGM (5) Changes in blood glucose SDlog on CGM (6) Comparison of the effects between URLi and Fiasp by measuring blood glucose 10 times a day and calculating the AUC (trapezoidal method) for the increase in blood glucose from before breakfast. (7) Comparison of the effects between URLi and Fiasp by CGM and calculating the AUC (trapezoidal method) for the increase in blood glucose from before breakfast.

—

Countries

Japan

Contacts

Public ContactDaisuke Tsuriya

Hamamatsu University School of Medicine Second Division, Department of Internal Medicine

dtsuri@hama-med.ac.jp053-435-2263

Outcome results

None listed

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