A Randomized, Single-center, Parallel-group, Prospective Trial of Neuroprotective Effect of Liraglutide for Treatment of Diabetic Polyneuropathy.

A Randomized, Single-center, Parallel-group, Prospective Trial of Neuroprotective Effect of Liraglutide for Treatment of Diabetic Polyneuropathy. - Treatment of Diabetic Poluneuropathy With Liraglutide

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021915

Enrollment

Registered

2016-04-16

Start date

2016-03-01

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

Diabetic Polyneuropathy

Interventions

Liraglutide, 0.9 mg/day, 2 years Control

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Correspond to all of the following in recruitment of participants with type 2 diabetes: 1. HbA1c: 7.0%<, <=13.0% 2. Diabetes treatment including diet therapy, exercise therapy, medication, and insulin therapy 3. Patients who meets more than 2 of 3 below: i) Bilateral neuropathic symptom of lower extremities ii) Bilateral decreased vibration sensation of lower extremities iii) Bilateral decrease or absence of Achilles tendon reflexes.

Exclusion criteria

Exclusion criteria: 1. Pregnancy, lactation 2. Allergic to Liraglutide 3. Past usage of GLP-1 receptor agonists or DPP4 inhibitors 4. Type 1 diabetes, othertypes of diabetes 5. Past history of diabetic ketoacidosis 6. Severe infection, Pre-/post-operation, Severe injuries 7. Treatment with steroids 8. Current/Past malignancy 9. Inappropriate patients for entry on this study in the judgement of the investigator

Design outcomes

Primary

Measure	Time frame
1. Change from screening in corneal confocal microscopic findings at month 36 2. Change from screening in nerve conduction studies at month 36	—

Secondary

Measure	Time frame
1. Score of Michigan Neuropathy Screening Instrument(MNSI) 2. Clinical findings: i) Absent or hypoactive Achilles tendon reflexes, ii) Impaired vibration sensation 3. HbA1c, blood glucose 4. Coefficients of variance of RR intervals 5. Diabetic nephropathy, Diabetic retinopathy 6. Laboratory data, blood pressure 7. Current perception threshold, Electronic pupillometer, Electroretinography 8. Mini Mental State Examination(MMSE) 9. Safety	—

Measure

Time frame

1. Score of Michigan Neuropathy Screening Instrument(MNSI) 2. Clinical findings: i) Absent or hypoactive Achilles tendon reflexes, ii) Impaired vibration sensation 3. HbA1c, blood glucose 4. Coefficients of variance of RR intervals 5. Diabetic nephropathy, Diabetic retinopathy 6. Laboratory data, blood pressure 7. Current perception threshold, Electronic pupillometer, Electroretinography 8. Mini Mental State Examination(MMSE) 9. Safety

—

Countries

Japan

Contacts

Public ContactTatsuhito Himeno

Aichi Medical University Diabetes

thimeno@aichi-med-u.ac.jp0561-63-1683

Outcome results

None listed

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