Skip to content

Investigation of efficacy and safety of basal supported oral therapy by alternate-day insulin degludec injection

Investigation of efficacy and safety of basal supported oral therapy by alternate-day insulin degludec injection - JUN-SIBA study:Juntendo-Soluble Insulin Basal Analogue study 3

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010885
Enrollment
40
Registered
2013-06-05
Start date
2013-06-06
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

Intervention group:injection of insulin every other day Control group:injection of insulin degludec every day

Sponsors

Juntendo University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)subjects with HbA1c(NGSP) 7.4 and more despite the treatment by medications 2)subjcets whose age are more than 20 years 3)no restriction on gender 4)written informed consent was obtained from all subjects after they had been provided with sufficient information about the study.

Exclusion criteria

Exclusion criteria: 1)Patients with past medical history of hypersensitivity to Degludec 2)Patients with hypoglycemia 3)Patients with serious liver,renal, pituitary and adrenal insufficiency. Patients with diarrhea, vomiting and other gastrointestinal problems. Patients with starvation state or unstable appetite. 4)Patients with serious diabetic complications including proliferative retinopathy (except for stable condition by photocoagulation). 5)Patients who are pregnant, hope to be pregnant, or are in lactation period. 6)Judged as ineligible by clinical investigators

Design outcomes

Primary

MeasureTime frame
Changes of HbA1c and fasting glucose levels from baseline

Secondary

MeasureTime frame
Daily glucose profile by SMBG Frequency and severity of hypoglycemia and other adverse events

Countries

Japan

Outcome results

None listed

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