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Examination of equivalence between biosimilar and original in insulin lispro

Examination of equivalence between biosimilar and original in insulin lispro - Examination of equivalence between biosimilar and original in insulin lispro

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042016
Enrollment
30
Registered
2020-10-06
Start date
2020-10-12
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

Interventions

Administer insulin lispro, which has been used so far, for 1 week, then change to biosimilar at the same dose and administer for 1 week.

Sponsors

Hamamatsu University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with type 1 or type 2 diabetes who have been treated with insulin lispro for at least 3 consecutive months before the start of this study

Exclusion criteria

Exclusion criteria: 1. Patients with severe ketosis, diabetic coma or precoma 2. Patients with severe infections, before and after surgery, and with serious external injury 3. Patients with severe renal dysfunction or end-stage renal disease on dialysis 4. Patients that the attending physician deems inappropriate for this study for other reasons

Design outcomes

Primary

MeasureTime frame
By wearing CGM, and blood glucose is continuously monitored weekly using each insulin to evaluate daily blood glucose profile (AUC).

Secondary

MeasureTime frame
(1) Change in Body weight (2) Number of occurrences of hypoglycemia (3) Variation of daily blood glucose profile (4) Comparison of average blood glucose revel from CGM data

Countries

Japan

Contacts

Public ContactDaisuke Tsuriya

Hamamatsu University School of Medicine Second Division, Department of Internal Medicine

dtsuri@hama-med.ac.jp053-435-2263

Outcome results

None listed

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