Effects of liraglutide add-on to insulin therapy in patients with type 2 diabetes

Effects of liraglutide add-on to insulin therapy in patients with type 2 diabetes - Effects of liraglutide add-on to insulin therapy in patients with type 2 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000030622

Enrollment

Registered

2017-12-29

Start date

2017-12-30

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: Patients with type 2 diabetes who fulfilled the following criteria. (1)Aged 20 and over;At the time of the initiation of insulin and liraglutide combination therapy (in outpatients) (2)The patients with insulin (in outpatients) Undergoing diagnosis of type 2 diabetes (3)Glycemic control;7.0 % <=HbA1c (4)The use content of existing oral medicine and insulin does not matter. Last Observation Carried Forward(LOCF) is applied in the following cases. Receiving an additional oral anti-diabetes drug or increasing the amount of use of oral anti-diabetes drug within 48 weeks after initiation of insulin and liraglutide combination therapy. (5)The patients who undergo a necessary testing item on analyzing this study

Exclusion criteria

Exclusion criteria: (1)Liraglutide induction by educational hospitalization of diabetes (2)Renal dysfunction (eGFR <30ml/min/1.73m2) (3)Steroid medication (4)Liver cirrhosis merger (5)Active Malignant neoplasm (6)Pregnant or lactating women (7)Decided as inappropriate for participating in this study by physician

Design outcomes

Primary

Measure	Time frame
Change in HbA1c over the 48-week treatment period.	—

Secondary

Measure	Time frame
Fasting plasma glucose(mg/dL),Glycated albumin(%) Body weight(kg),Body mass index(BMI) Insulin dose(units/day) CPR-index,HOMA2-%beta(%) HOMA2-IR Urine albumin/creatinine ratio(mg/gCr) Systolic blood pressure(mmHg),Diastolic blood pressure(mmHg),Pulse rate Lipid profile UA(mg/dL) AST,ALT,gamma-GTP BUN(mg/dL),Serum creatinine(mg/dL),eGFR (ml/min/1.73m2),cystatinC(mg/L) Hypoglicemic events Other adverse events	—

Measure

Time frame

Fasting plasma glucose(mg/dL),Glycated albumin(%) Body weight(kg),Body mass index(BMI) Insulin dose(units/day) CPR-index,HOMA2-%beta(%) HOMA2-IR Urine albumin/creatinine ratio(mg/gCr) Systolic blood pressure(mmHg),Diastolic blood pressure(mmHg),Pulse rate Lipid profile UA(mg/dL) AST,ALT,gamma-GTP BUN(mg/dL),Serum creatinine(mg/dL),eGFR (ml/min/1.73m2),cystatinC(mg/L) Hypoglicemic events Other adverse events

—

Countries

Japan

Contacts

Public ContactHirotatsu Nakaguchi

Yokohama City University Graduate School of Medicine Department of Endocrinology and Metabolism

t156054d@yokohama-cu.a.jp045-787-2639

Outcome results