Efficacy and safety of degludec/liraglutide combination injection switching from basal insulin therapy with the DPP-4 inhibitor in Japanese type 2 diabetic patients

Efficacy and safety of degludec/liraglutide combination injection switching from basal insulin therapy with the DPP-4 inhibitor in Japanese type 2 diabetic patients - Efficacy and safety of Xultophy combination injection switching from basal insulin therapy with the DPP-4 inhibitor in Japanese type 2 diabetic patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000038667

Enrollment

Registered

2019-11-23

Start date

2020-01-01

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 diabets

Interventions

Switching from basal insulin and 20mg/day teneligliptin to insulin degludec/liraglutide combination injection over 24 weeks. Basal insulin is titrated with the aim of achieving a fasting self-monitore

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Patients with type 2 diabetes ; age between 20 and 90 years 2. Patients with basal insulin and 20mg/day teneligliptin more than 8 weeks before intervention 3. Patients who showed HbA1c levels 7.0% to 11.0% 4. Patients without change of oral anti-diabetic medications over 8 weeks before intervention

Exclusion criteria

Exclusion criteria: 1. Patients with insulin therapy except basal insulin 2. Patients with GLP-1 receptor agonist 3. Patients with severe liver dysfunction 4. Patients with severe infection, operation, trauma 5. Patients with steroid medication 6. Patient with erythropoietin therapy 7. Patients with malignant tumors 8. Patients who have pregnancy or possibilty of pregnancy, or are under lactation 9. Patients who have hypersensitivity to insulin degludec, liraglutide, or teneligliptin 10. Patients who are considered to be not eligible to the study by the doctor

Design outcomes

Primary

Measure	Time frame
Comparing the two groups change in HbA1c over the 24-week treatment period	—

Secondary

Measure	Time frame
1. Fasting plasma glucose 2. Body weight 3. creatinine 4. eGFR 5. Urine albumin/creatinine ratio 6. Lipid profile 7. Insulin dose 8. Frequency of hypoglycemia 9. Other adverse event	—

Countries

Japan

Contacts

Public ContactShunsuke Yamazaki

Fujisawa City Hospital Department of Diabetology and Endocrinology

yamazaki-s@umin.ac.jp0466-25-3111

Outcome results

None listed

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