Skip to content

The efficacy and the safety of the new long-acting insulin in patient with diabetes

The efficacy and the safety of the new long-acting insulin in patient with diabetes - The efficacy and the safety of the new long-acting insulin in patient with diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020521
Enrollment
100
Registered
2016-01-11
Start date
2016-01-11
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

diabetes

Interventions

concentrated preparation of insulin glargine The dosing period is from start of examination to implementation of the questionnaire 3~6 months after.We set the dose to the target of less than HbA1c7%

Sponsors

Osaka Saiseikai Noe Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients whose HbA1c are more than 8.0% or who are already using insulin

Exclusion criteria

Exclusion criteria: Contraindicated patient in the attached document of the insulin preparations Contraindicated patient in the attached document of diabetes drugs Hypoglycemic risk Serious heart trouble Severe hepatic dysfunction Severe renal dysfunction Internal secretion disease Needs the steroid dosage Patients judged by the investigator to be ineligible for some other reason

Design outcomes

Primary

MeasureTime frame
Change in HbA1c, the body weight, the custom-built diabetes treatment satisfaction questionnaire result and adverse events including hypoglycemia at 24weeks later from an examination start

Secondary

MeasureTime frame
From an examination start, it is the following items 24 weeks later -Achievement rate of HbA1c<7.0% and<8.0% -Change in fasting blood glucose -Glycemic variability by SMBG -Change in insulin dose(daily basal insulin doses, daily total insulin doses)

Countries

Japan

Contacts

Public ContactMitsuru Ota

Osaka Saiseikai Noe Hospital Department of Diabetes and Endocrinology

mitsuru.ota@noe.saiseikai.or.jp06-6932-0401

Outcome results

None listed

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