Two-way crossover comparison of insulin glargine and insulin degludec in basal-bolus therapy using continuous glucose monitoring.

Two-way crossover comparison of insulin glargine and insulin degludec in basal-bolus therapy using continuous glucose monitoring. - Two-way crossover comparison of insulin glargine and insulin degludec in basal-bolus therapy using continuous glucose monitoring.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013285

Enrollment

Registered

2014-03-01

Start date

2013-05-21

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 diabetes or type 2 diabetes

Interventions

The patient&#39

s prior long-acting insulin analog is discontinued and replaced with insulin glargine. The CGM examination is carried out at least 14 days after switching insulin. Insulin glargine is changed to insul

s prior long-acting insulin analog is discontinued and replaced with insulin degludec. The CGM examination is carried out at least 14 days after switching insulin. Insulin degludec is changed to insul

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diabetic patients who were prescribed basal-bolus insulin therapy with long-acting insulin analog as basal insulin.

Exclusion criteria

Exclusion criteria: Patients with diabetic nephropathy more than stage 3 (urinary albumin 300mg/gCr or urinary protein 0.5g/gCr) or with abnormal aspartate aminotransferase/alanine aminotransferase elevation (3 X the upper limit of normal) were excluded from this study.

Design outcomes

Primary

Measure	Time frame
Glycemic control is estimated as the mean blood glucose (MBG), the area under the glucose curve above 10.0 mmol/L (area under the curve [AUC]>10), and the percentage of time above 10.0mmol/L (t>10). The AUC is calculated using the trapezoidal method. Intraday glycemic variability is assessed as the standard deviation (SD) and the mean amplitude of glycemic excursions (MAGE). Day-to-day glycemic variability is assessed as the mean of daily difference (MODD). Hypoglycemia, which is defined as a sensor value of <3.9 mmol/L, was also calculated as a total time at <3.9 mmol/L. Severe hypoglycemia is defined as a sensor value of <2.8 mmol/L.	—

Measure

Time frame

Glycemic control is estimated as the mean blood glucose (MBG), the area under the glucose curve above 10.0 mmol/L (area under the curve [AUC]>10), and the percentage of time above 10.0mmol/L (t>10). The AUC is calculated using the trapezoidal method. Intraday glycemic variability is assessed as the standard deviation (SD) and the mean amplitude of glycemic excursions (MAGE). Day-to-day glycemic variability is assessed as the mean of daily difference (MODD). Hypoglycemia, which is defined as a sensor value of <3.9 mmol/L, was also calculated as a total time at <3.9 mmol/L. Severe hypoglycemia is defined as a sensor value of <2.8 mmol/L.

—

Countries

Japan

Contacts

Public ContactInoue Gaku

Kitasato University School of Pharmacy Center for Clinical Pharmacy and Clinical Sciences

inoueg@pharm.kitasato-u.ac.jp03-5791-6359

Outcome results

None listed

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