An investigation of therapeutic efficacy when switching from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin in type 2 diabetes patients

An investigation of therapeutic efficacy when switching from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin in type 2 diabetes patients - An investigation of therapeutic efficacy when switching from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin in type 2 diabetes patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000036788

Enrollment

Registered

2019-05-18

Start date

2019-04-01

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

Dulaglutitde group: switch from intensive insulin therapy to long-acting insulin plus dulaglutide(0.75mg/week). The primary endpoint is the change in HbA1c level from immediately before switching tre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who have been undergoing treatment with intensive insulin therapy alone for or over12 weeks 2. Age or over 18 years and under 90 years 3. BMI under 45 kg/m2 4. Negative for anti-GAD antibodies

Exclusion criteria

Exclusion criteria: 1. Patients with serious hepatic dysfunction 2. Patients with serious renal dysfunction 3. Patients taking steroids 4. Patients with cancer 5. Patients with severe infection or serious injury 6. Patients who are or could be pregnant 7. Patients with an allergy to the drug to be used or for whom it is contraindicated 8. Any other patients considered by the investigator or a subinvestigator to be unsuitable to participate in the study

Design outcomes

Primary

Measure	Time frame
Change in HbA1c from before switching treatment to 24 weeks after switching	—

Secondary

Measure	Time frame
fasting blood glucose 2-h postprandial glucose GA insulin secretion capacity pancreatic glucagon flash glucose monitoring Self-monitoring of blood glucose results renal function urinary albumin L-FABP Body weight BMI body composition waist circumference blood pressure heart rate lipids UA hepatic function total protein albumin electrolytes insulin dose Evaluation of satisfaction with treatment appetite Adverse events	—

Measure

Time frame

fasting blood glucose 2-h postprandial glucose GA insulin secretion capacity pancreatic glucagon flash glucose monitoring Self-monitoring of blood glucose results renal function urinary albumin L-FABP Body weight BMI body composition waist circumference blood pressure heart rate lipids UA hepatic function total protein albumin electrolytes insulin dose Evaluation of satisfaction with treatment appetite Adverse events

—

Countries

Japan

Contacts

Public ContactKohei Ito

Chigasaki Municipal Hospital Division of Endocrinology & Metabolism

t186011a@yokohama-cu.ac.jp0467-52-1111

Outcome results

None listed

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