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Efficacy and safety of once daily insulin IDeg/Asp switching from basal insulin in inadequately controlled Japanese patients with type 2 diabetes: A 4-week, randomized, open-label, treat-to-target trial

Efficacy and safety of once daily insulin IDeg/Asp switching from basal insulin in inadequately controlled Japanese patients with type 2 diabetes: A 4-week, randomized, open-label, treat-to-target trial - Efficacy and safety of IDegAsp switching from basal insulin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021629
Enrollment
40
Registered
2017-01-01
Start date
2016-04-01
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 2 diabetes

Interventions

basal insulin IDegAsp

Sponsors

St. Marianna University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Outpatients Current oral antidiabetic drug(s) treatment with Iglar or IDeg 7.0% <= HbA1c <= 9.0% BMI <=35 kg/m2

Exclusion criteria

Exclusion criteria: The exclusion criteria were pregnancy, severe illness, CKD (eGFR < 30 ml/min/1.73m2), and malignancy.

Design outcomes

Primary

MeasureTime frame
Change in AUC-Glu during test meal loading before and after switching from basal insulin to IDegAsp

Secondary

MeasureTime frame
Change from baseline in insulin dose (U) after 4 weeks of treatment Changes from baseline in FPG, GA, and 1,5-AG after 4 weeks of treatment Beta-cell stress assessed by the change of plasma intact proinsulin / C-peptide ratio

Countries

Japan

Contacts

Public ContactYoshio Nagai

St. Marianna University School of Medicine Division of Metabolism and Endocrinology, Department of Internal Medicine

ynagai@marianna-u.ac.jp044-977-8111

Outcome results

None listed

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