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Investigation of efficacy and safety of insulin degludec or insulin glargine in type 2 diabetes with basal-bolus therapy

Investigation of efficacy and safety of insulin degludec or insulin glargine in type 2 diabetes with basal-bolus therapy - JUN-SIBA study:Juntendo-Soluble Insulin Basal Analogue study 4

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013872
Enrollment
60
Registered
2014-05-07
Start date
2014-05-01
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

Conventional group: to adjust the amount of insulin glargine according to the algorithm Change group: to perform switching in the same unit to insulin degludec from insulin glargine, to adjust the amo

Sponsors

Juntendo University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Fasting blood glucose is inadequately-controlled patients at 140 mg/dl or more 2)Patients who have done more than 6 months Basal-Bolus Therapy 3)BMI less than 35kg/m2

Exclusion criteria

Exclusion criteria: 1)hypersensitivity to degludec 2)patient with hypoglycemia 3)patient with serious liver and kidney disease 4)patient with proliferative retinopathy 5)during pregnancy and lactation

Design outcomes

Primary

MeasureTime frame
1. MAGE and MODD by CGM 2. nocturnal hypoglycemia frequency

Countries

Japan

Contacts

Public ContactFuki Ikeda

Juntendo University Graduate School of Medicine Department of Metabolism & Endocrinology

fuki@juntendo.ac.jp03-3813-3111

Outcome results

None listed

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