Efficacy and safety of insulin glargine 300 U/ml versus 100 U/ml in type 2 diabetic patients treated with basal insulin plus GLP-1 receptor agonist

Efficacy and safety of insulin glargine 300 U/ml versus 100 U/ml in type 2 diabetic patients treated with basal insulin plus GLP-1 receptor agonist - Efficacy and safety of insulin glargine 300 U/ml versus 100 U/ml in type 2 diabetic patients treated with basal insulin plus GLP-1 receptor agonist

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019353

Enrollment

Registered

2015-10-14

Start date

2015-10-14

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

Injecting insulin glargine 100 U/ml before breakfast in period 1, and insulin glargine 300 U/ml before breakfast in period 2. Injecting insulin glargine 300 U/ml before breakfast in period 1, and ins

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - adults with type 2 diabetes - treated with a basal insulin - treated with a GLP-1 receptor agonist (regardless of couse of oral hypoglycemic agents)

Exclusion criteria

Exclusion criteria: - patients injecting bolus insulin - patients expected to have other antidiabetic agents added, changed, or increased/decreased in dosage during the next 6 months - difficulty to perform self-monitoring blood glucose - Patients with severe hepatic, renal, and/or cardiac disease - Patients with hypersentitivity to the agents used in the current study - Patients who are pregnant, breast-feeding or may become pregnant - Patients who are judged by the investigator to be inappropriate for this study for any other reason.

Design outcomes

Primary

Measure	Time frame
glucose-lowering effect evaluated with HbA1c levels after three-month treatment	—

Secondary

Measure	Time frame
- glucose-lowering effect evaluated with self-monitored blood glucose levels - Subjective assessment of insulin injection - Adverse events including hypoglycemia, weight gain, and other side effects	—

Countries

Japan

Contacts

Public ContactToshihiko Shiraiwa

Shiraiwa Medical Clinic Shiraiwa Medical Clinic

shiraiwa@endmet.med.osaka-u.ac.jp072-971-1221

Outcome results

None listed

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