Study for the efficacy and appropriate dosing of insulin degludec, an ultra long-acting insulin, in patients with type 1 diabetes

Study for the efficacy and appropriate dosing of insulin degludec, an ultra long-acting insulin, in patients with type 1 diabetes - Study for the efficacy and appropriate dosing of insulin degludec, an ultra long-acting insulin, in patients with type 1 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010634

Enrollment

Registered

2013-05-01

Start date

2013-03-07

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 1 diabetes mellitus

Interventions

In patients those who are injecting long-acting insulin (1) once daily or (2) twice daily, long-acting insulin are switched to insulin degludec once daily injection. Initial degludec doses are transfe

KITANO Tresiba protocol&quot

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with type 1 diabetes who are on insulin basal-bolus therapy 2. Age: >20 years-old

Exclusion criteria

Exclusion criteria: 1. The patients who did not agree with this study 2. The patients with serious complications 3. The patients who are at high risk for hypoglycemia 4. The patients who have the history of severe hypoglycemia (needed an emergency transport according to the hypoglycemia unawareness) 5. Those who are not approved to be eligible to this study by corresponding researcher or co-researchers

Design outcomes

Primary

Measure	Time frame
Changes in HbA1c at 4, 12 and 24 weeks and insulin dose	—

Secondary

Measure	Time frame
Changes in mean blood glucose level, SD value, MAGE value, rate and duration of hyper/hypoglycemia, glycemic pattern and area under the carve after long-acting insulin injection, (evaluated by SMBG/CGM), body weight, and frequency of hypoglycemia	—

Countries

Japan

Outcome results

None listed

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