Clinical Study on rapid-acting insulin analog in intensive basal and bolus insulin therapy ~ Efficacy and safety of glulisine-based multiple daily injection therapy in Japanese diabetic patients

Clinical Study on rapid-acting insulin analog in intensive basal and bolus insulin therapy ~ Efficacy and safety of glulisine-based multiple daily injection therapy in Japanese diabetic patients - Clinical Study on rapid-acting insulin analog in intensive basal and bolus insulin therapy ~ Efficacy and safety of glulisine-based multiple daily injection therapy in Japanese diabetic patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010702

Enrollment

100

Registered

2013-05-13

Start date

2012-04-01

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 1 and type 2 diabetes mellitus

Interventions

Diabetic patients with &amp

#8805

HbA1c6.2% who were treated with bolus insulin -Asp, Lisp, was changed to the same unit of Gl along with diet and exercise. Basal insulin dosage is basically not changed. They were observed for 24 week

120mg/dL, PPG&lt

160mg/dL, and insulin dosage was adjusted with judgment of the consulting doctors

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Type 1 or 2 diabetes patients who were treated with bolus insulin -Asp or Lisp and basal insulin -glargine more than 8 weeks. 2) HbA1c &#8805; 6.2% 3) Over 20 years old 4) Voluntarily signed to the consent form after taking enough explanation of the significance and the objectives of this study

Exclusion criteria

Exclusion criteria: 1) Inability to provide informed consent 2) Patients with sever ketosis, coma diabeticum, pre coma diabeticum in the last 6 months 3) Patients with serious infection, pre/post surgery, or sever external injury 4) Pregnancy or patients with possibility of pregnancy, patients with breath feeding 5) Patients who are not appropriate to participate this investigation judged by the consulting doctor

Design outcomes

Primary

Measure	Time frame
Efficacy endpoints: Amounts and changing value of blood glucose control markers (HbA1c, blood glucose, glycosylated albumin and 1.5-AG) and diabetic complication markers (urinary albumin excretion ratio, s-RAGE, MCP-1 and TAGE) for each measurement point will be evaluated with descriptive statistics Safety endpoints: The incident rate and the situation of side effects and adverse events during observation and treating periods. Laboratory evidence is the use of descriptive statistics.	—

Measure

Time frame

Efficacy endpoints: Amounts and changing value of blood glucose control markers (HbA1c, blood glucose, glycosylated albumin and 1.5-AG) and diabetic complication markers (urinary albumin excretion ratio, s-RAGE, MCP-1 and TAGE) for each measurement point will be evaluated with descriptive statistics Safety endpoints: The incident rate and the situation of side effects and adverse events during observation and treating periods. Laboratory evidence is the use of descriptive statistics.

—

Countries

Japan

Outcome results

None listed

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