Insulin degludec compared with conventional basal insulin in basal-bolus therapy with type 1 and type2 diabetes in outpatient: A 24-week, randomized, open-label, treat-to-target trial

Insulin degludec compared with conventional basal insulin in basal-bolus therapy with type 1 and type2 diabetes in outpatient: A 24-week, randomized, open-label, treat-to-target trial - Showa university Examines the Effects of Insulin Degludec

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021046

Enrollment

200

Registered

2016-03-01

Start date

2013-08-10

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

.Insulin degludec(24weeks) .Initial insulin doses were replased with insulin degludec or conventional basal insulin in a 1:1 ratio(enable the basal insulin dose decrease by the judgment of the inve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Type 1 and Type 2 diabetes receiving Basal-bolus insulin therapy in outpatient 2.All subjects had been treated with basal-bolus insulin therapy for>4 months prior to trial acreening 3.In the case of type 1 diabetes, a duration of a disease is more than 12 months 4.The patients who are available for self monitoring of blood glucose 5.Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in this examination

Exclusion criteria

Exclusion criteria: 1.Patients with a history of hypersensitivity to insulin 2.Patients with severe ketosis, diabetic coma or the former comatose 3.Patients with severe renal dysfunction including the patients needing haemodialysis or peritoneal dialysis 4.Patients with the pre or proliferative retinopathy,including in the vitreous haemorrhage risk. 5.Patients with the serious infection, the perioperative period and the serious trauma 6.Patients with the pregnant woman or the woman who may be pregnant 7.In addition, the patient who judged inappropriate by an attendant physician

Design outcomes

Primary

Measure	Time frame
The change in HbA1c after 16weeks of treatment from baseline	—

Secondary

Measure	Time frame
Hypoglycemic episodes Change in fasting glucose levels 6-points SMBG profiles DTSQs scale score The change in HbA1c after 24weeks of treatment from baseline	—

Countries

Japan

Contacts

Public ContactTomoyasu Fukui

Showa University School of Medicine Department of Medicine, Division of Diabetes, Metabolism and Endocrinology

showauft@med.showa-u.ac.jp03-3784-8000

Outcome results

None listed

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