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The efficacy of insulin degludec/insulin aspart switching from insulin glargine or degludec about glycemic metabolism in type 2 diabetes patients

The efficacy of insulin degludec/insulin aspart switching from insulin glargine or degludec about glycemic metabolism in type 2 diabetes patients - The efficacy of insulin degludec/insulin aspart switching from existing long acting insulin in type 2 diabetes patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025199
Enrollment
60
Registered
2016-12-09
Start date
2016-12-19
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

Keeping insulin degludec or insulin glargine Switching from insulin degludec or insulin glargine to insulin degludec/insulin aspart

Sponsors

Hokkaido University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who were 20-year-old to 80-year-old at the time of obtaining informed consent 2) Patients whose HbA1c level is more than 6.0% and less than 9.0% at the time of obtaining informed consent 3) Patients who were taking insulin degludec or insulin glargine once daily more than three months and measuring their blood glucose by SMBG 4) Patients who are able to understand the study and willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with hypersensitivity to insulin degludec/ insulin aspart 2) Patients with severe or unstable retinopathy 3) Patients with severe liver or kidney dysfunction 4) Patients with pregnancy 5) Patients with severe diabetic ketosis, diabetic coma 6) Patients who are obviously bad adherence of diet. 7) Patients who needs intensive insulin therapy due to whose insulin depletion 8) Patients who are deemed to be unsuitable by the investigator

Design outcomes

Primary

MeasureTime frame
Difference between pre-prandial blood glucose level and postprandial blood glucose level in main meal measured by SMBG at 12 weeks after intervention.

Secondary

MeasureTime frame
1) Glucose variability measured by SMBG 2) Blood and urine test (including HbA1c) 3) Body weight 4) Incidence rate of hypoglycemia 5) Dose of insulin and other antidiabetic agent

Countries

Japan

Contacts

Public ContactKyu Yong Cho

Hokkaido University Hospital Department of Medicine 2/Clinical Research and Medical Innovation Center

kyuyong-cho@med.hokudai.ac.jp011-706-7735

Outcome results

None listed

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