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The Effect of High Concentration Insulin Glargine to the Quality of Life of the Patients with Type 2 Diabetes Mellitus: A Pre-Post Study.

The Effect of High Concentration Insulin Glargine to the Quality of Life of the Patients with Type 2 Diabetes Mellitus: A Pre-Post Study. - The Effect of High Concentration Insulin Glargine to the Quality of Life of the Patients with Type 2 Diabetes Mellitus: A Pre-Post Study (HIGH-QOL study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023842
Enrollment
150
Registered
2016-09-01
Start date
2016-09-01
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 mellitus

Interventions

Patients who use no less than 30 units of standard concentration insulin glargine (100 units/mL) per shot will be switched to high concentration insulin glargine (300 units/mL) at same dosage, except

Sponsors

NHO Kyoto Medical Center, Diabetes Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes mellitus, who are hospitalized at or regularly visit the participating hospitals/clinics, who uses standard concentration insulin glargine for no less than 4 weeks, and who provides consent to change it to high concentration insulin glargine.

Exclusion criteria

Exclusion criteria: (1) Patients who already use high concentration insulin glargine. (2) Patients who are pregnant or under preconception care. (3) Patients to whom usage of insulin glargine is considered to be inappropriate for any reason.

Design outcomes

Primary

MeasureTime frame
Change in the pain accompanied by injection

Secondary

MeasureTime frame
Change in the score regarding the easiness to use the injection device, adverse events, baseline HbA1c, age, sex, height, body weight, diabetic retinopathy, diabetic nephropathy, diabetic peripheral polyneuropathy, frequency of self monitoring of blood glucose, pharmacotherapy (insulin, other medication), place of injection.

Countries

Japan

Contacts

Public ContactTakashi Murata

NHO Kyoto Medical Center Diabetes Center

murata-tky@umin.net075-641-9161

Outcome results

None listed

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