Comparison of insulin degludec/liraglutide versus insulin degludec in multiple daily injection therapy on subjects with type 2 diabetes; time to reach target glycemic levels

Comparison of insulin degludec/liraglutide versus insulin degludec in multiple daily injection therapy on subjects with type 2 diabetes; time to reach target glycemic levels - Conparison of IDegLira vs IDeg in multiple daily injection therapy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000052156

Enrollment

Registered

2023-09-09

Start date

2023-09-05

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Type 2 diabetes subjects on treatment with oral hypoglycemic agents only 2) Subjects with HbA1c more than 7% 3) Subjects aged 20 years or older at the time of consent 4) Those who have received sufficient explanation before participating in this research, and who have obtained the voluntary consent of the research subject after receiving sufficient understanding, or who do not refuse to participate in the research.

Exclusion criteria

Exclusion criteria: 1) Subjects on GLP-1 receptor agonists and insulin preparations as pre-treatment 2) Type 1 diabetes mellitus 3) Subjects who are deemed to be unsuitable by the investigator

Design outcomes

Primary

Measure	Time frame
Differences in the number of therapeutic days to achieve the glycemic target between the multiple injection therapy group with insulin degludec/liraglutide injection (IDegLira-MDI) and with insulin degludec.	—

Secondary

Measure	Time frame
1) Total daily dose of insulin when the target blood glucose was achieved. 2) Mean amplitude of glycemic excursions on a continuous glucose met 3) Other blood and urine tests (liver function, renal function, blood glucose, bone metabolism, secretory capacity, etc.) 4) ABI, CAVI, PWV in arteriosclerosis test 5) Body composition 6) Diurnal blood glucose variability index by treatment (%CV, M value, SD, ADRR(average daily risk range) in addition to MAGE) 7) 24-hour average blood glucose level 8) Percentage of time in target range (TIR) 9) Percentage of time below target range (TBR) 10) Percentage of time above target range (TAR) 11) Mean of daily difference of blood glucose 12) Blood glucose AUC, MAGE, SD, and MODD by time period 13) Relationships with patient background and laboratory values affecting the above data 14) Questionnaires related to diabetes treatment satisfaction and quality of life (DTR-QOL, eating behavior questionnaire) 15) Medications and blood/urine tests including HbA1c, weight, etc. in the outpatient clinic after completion of the treatments	—

Measure

Time frame

1) Total daily dose of insulin when the target blood glucose was achieved. 2) Mean amplitude of glycemic excursions on a continuous glucose met 3) Other blood and urine tests (liver function, renal function, blood glucose, bone metabolism, secretory capacity, etc.) 4) ABI, CAVI, PWV in arteriosclerosis test 5) Body composition 6) Diurnal blood glucose variability index by treatment (%CV, M value, SD, ADRR(average daily risk range) in addition to MAGE) 7) 24-hour average blood glucose level 8) Percentage of time in target range (TIR) 9) Percentage of time below target range (TBR) 10) Percentage of time above target range (TAR) 11) Mean of daily difference of blood glucose 12) Blood glucose AUC, MAGE, SD, and MODD by time period 13) Relationships with patient background and laboratory values affecting the above data 14) Questionnaires related to diabetes treatment satisfaction and quality of life (DTR-QOL, eating behavior questionnaire) 15) Medications and blood/urine tests including HbA1c, weight, etc. in the outpatient clinic after completion of the treatments

—

Countries

Japan

Contacts

Public ContactYuki Oe

Kushiro Red Cross Hospital Internal Medicine

o-e.yuki@med.hokudai.ac.jp0154-22-7171

Outcome results