Study on dose adjustment of insulin glargine in type 2 diabetic patients treated with basal supported oral therapy

Study on dose adjustment of insulin glargine in type 2 diabetic patients treated with basal supported oral therapy - Adjust KOBE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014350

Enrollment

160

Registered

2014-08-01

Start date

2014-10-20

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 mellitus

Interventions

In doctor-led titration group, subjects adjust insulin glargine dose according the clinical judgement of their physicians at the time of consultation one or more times in four weeks. Physicians adjus

130mg/dl. There is no change of the timing to insulin administration, no adjustment of other hypoglycemic agent and no addition of any other drugs which effect glucose metabolism during study period.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: type 2 diabetic patients suboptimally controlled with basal supported oral therapy using insulin glargine HbA1c levels >=7.0% and <=11.0% feasible to perform self-monitoring blood glucose at least once (before breakfast) daily in patients without sulfonylurea and at least twice (before breakfast and dinner) daily in patients with sulfonylurea disease duration >=2 years no change of oral hypoglycemic agent within preceding a month feasible to record data from SMBG and complete questionnaires

Exclusion criteria

Exclusion criteria: diabetes other than type 2 diabetes mellitus history of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty or other severe cardiac disease within the preceding 12 months severe renal dysfunction (serum creatinine >2.0mg/dl) severe liver dysfunction (serum aspartate aminotransferase or alanine aminotransferase >=2.5 times the normal upper limit active proliferative diabetic retinopathy or none of ophthalmologic examination in the past 12 months history of hypoglycemia unawareness pregnancy or breast-feeding

Design outcomes

Primary

Measure	Time frame
indicators of glycemic control such as HbA1c and glycoalbumin	—

Secondary

Measure	Time frame
frequency of hypoglycemia, frequency of severe hypoglycemia, mean fasting blood glucose determined with self-monitoring blood glucose, change of insulin glargine dose, change of DTSQ score, change of weight	—

Countries

Japan

Contacts

Public ContactKazuhiko Sakaguchi

Kobe University Graduate School of Medicine Division of Diabetes and Endocrinology

kzhkskgc@med.kobe-u.ac.jp078-382-5861

Outcome results

None listed

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