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the effect of insulin glargine U300 on variability of glucose level before breakfast and change in HbA1c level -pre and post comparison test by switching from U100 to U300-

the effect of insulin glargine U300 on variability of glucose level before breakfast and change in HbA1c level -pre and post comparison test by switching from U100 to U300- - evaluation for Fasting PG stabilization by switching therapy from glargine to U300 (FASTAGLU300 Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025502
Enrollment
100
Registered
2017-02-01
Start date
2017-01-10
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 mellitus

Interventions

switching from insulin glargine U100 to U300 in the same unit during 30 days adjuasting insulin dose by using self-titration algorithm (3-3-1 algorithm) during 90 days

Sponsors

Fukuiken Saisekai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)patient with type 1 or 2 diabetes treated with once daily insulin glargin for moer than 12 weeks (2) HbA1c(NGSP) 7.0 - 11.0% (3) Patients who can continue self-monitoring of fasting blood glucose in early morning (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 judged by their primary physician that they are not appropriate to participate the study.

Design outcomes

Primary

MeasureTime frame
1.Changes in mean value and standard deviation (SD)of fasting blood glucose in early morning 2.Changes in HbA1c and glycated albumin levels after self-titration algorithm (3-3-1 algorithm)

Secondary

MeasureTime frame
1.Contributing factors on SD of fasting blood glucose in early morning 2. Change in patient feeling of use 3. Change in body weight,blood pressure and lipid profile 4.symptomatic or severe hypoglycemia 5. another adverse events and side effects

Countries

Japan

Contacts

Public ContactKazuo Notsumata

Fukuiken Saisekai Hospital Internal medicine

bando.yukihiro5002@fukui.saiseikai.or.jp0776231111

Outcome results

None listed

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