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the efficiency and safety of rapid acting insulin, glulisine, in the diabetic patients treated with intensive insulin therapy

the efficiency and safety of rapid acting insulin, glulisine, in the diabetic patients treated with intensive insulin therapy - bolus insulin adjust nice control by apidra(BANDRA study)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008797
Enrollment
50
Registered
2012-08-29
Start date
2012-04-01
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

swith from lispro or aspart to glirisine added 1 unit.

Sponsors

Fukuiken Saiseikai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) patient with type 1 or 2 diabetes treated with rpid acting insulin, lipro or aspart for moer than 12 weeks (2) HbA1c(NGSP) 7.5 - 10.5% (3) Duration of diabetes within 10 years (4) Age, 20 - 50 year old (5) Patients who can agree to take part in this study

Exclusion criteria

Exclusion criteria: -Patients who do not consent to the study. -Patients who have had severe ketosis or who have been in a diabetic coma or precoma within the past 6 months. -Patients who have a severe infection, are in pre/post operation, or have a serious wound. -Patients who are pregnant, lactating or may become pregnant. -Patients who have more than moderate kidney impairment (creatinine clearance is less than 30ml/min.) -Patients judged by their primary physician that they are not appropriate to participate the study.

Design outcomes

Primary

MeasureTime frame
1. the diference of HbA1c 2. the diference of GA 3. GA/HbA1c (at 12th week, 24th week) 4. the rate of HbA1c 7.5% acheived

Secondary

MeasureTime frame
1. the diference of body weight 2. severe hypoglycemia needed a treatment in hospital 3. DTSQ 4. anyother adverse events and side effects

Countries

Japan

Contacts

Public ContactKazuo Notsumata

Fukuiken Saiseikai Hospital Internal medicine

Y-bando@fukui.saiseikai.or.jp0776231111

Outcome results

None listed

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