Study of the efficacy and safety of insulin degludec who treating with basal insulin glargine or insulin detemir in type 2 diabetes with the Basal-Bolus Therapy

Study of the efficacy and safety of insulin degludec who treating with basal insulin glargine or insulin detemir in type 2 diabetes with the Basal-Bolus Therapy - Degludec and Insulin Rapid ExChange study in TOHO for T2D

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015792

Enrollment

Registered

2014-11-29

Start date

2013-11-01

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

Until December 2015. The basal insulin changes to insulin glargine or insulin degludec. Set to the same dose of the basal insulin before treatment dose of basal insulin. The subcutaneous injection onc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Type 2 diabtes patients who had diagnosed 12 months ago. (2)Patients medicated basal-bolus therapy for more than 12 month (3) Adalts who are 20 years or older (4) 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) Type 1 diabetes mellitus patients (2) Patients with severe liver disease (3) Patients with severe renal disease (4) Patients who had myocardial infarction within 3 months, or obvious heart failure case (5) Patients with severe pancreas disease (6) Patients having a cancer (7) Patients with hemoglobin (Hb) less than 11 g/dL (8) Patients that the number of the platelets is less than 100,000 /mm3 (9) Patients with high diabetic neuropathy (10) Patients having a proliferative retinopathy (11) Patients with a serious infectious disease or a serious injury (12) Patients with bowel disease or ileus factors (13) Chronic enteropathy patients with the digestion and absorption abnormality (14) Excessive common custom drinker (15) A pregnant woman or the woman who may be pregnant (16) Patients who was infected with hepatitis B virus or hepatitis C virus (17) In addition, the patient who judged inappropriate by an attendant physician

Design outcomes

Primary

Measure	Time frame
Daily glucose fluctuation (MAGE,SD), incidence of hypoglycemia, change of QOL,change of HbA1c,Ratio of bolus inslin and basal insulin	—

Countries

Japan

Contacts

Public ContactRyo Iga

Toho University School of Medicine Division of diabetes, metabolism and endocrinology

ryou.iga@med.toho-u.ac.jp03-3762-4151

Outcome results

None listed

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