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Clinical Study on the Improvement of Diabetic Neuropathic Pain by Liraglutide

Plain-language guide to NCT04137328: not phased randomized trial of Insulin (regular human) and Liraglutide, 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04137328
Phase
not phased
Status
status unknown
Start
2019-11-30
Completion (planned or actual)
2022-11-30
Participants
60 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Diabetic Neuropathic Pain
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Insulin (regular human) and Liraglutide.

Diabetic neuropathic pain is a common clinical manifestation of diabetic neuropathy, which seriously affects the quality of life of patients.

The clinical treatment is limited and the curative effect is not good.

It had two arms (groups): liraglutide group (experimental) and control group (active comparator).

The registry classes the interventions as drug.

More on the Plan

Diabetic neuropathic pain seriously affects the quality of life, clinical problems are difficult, and new treatment methods are urgently needed.

Diabetic neuropathy is one of the most common complications of diabetes mellitus.

The most common type of diabetic peripheral neuropathy is distal symmetric polyneuropathy, which is the main cause of diabetic neuropathic pain (DNP).

At present, the first-line clinical treatment drugs include pregabalin, duloxetine, amitriptyline, gabapentin and venlafaxine, etc., and these drugs sometimes relieve the symptoms of diabetic neuropathic pain not obvious, and have more side effects, which has become a difficult problem in clinical treatment.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and care provider.

It started in 2019-11-30 with completion listed for 2022-11-30.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Numerical pain scale (NRS) (time frame: 3 months).

It also tracked 2 secondary outcomes, for example Neurological symptom score (NSS) / neurological deficit score (NDS) and Examination of nerve conduction function.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) and Liraglutide in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page and the Liraglutide compound page, all human trials.

Our Notes on the Compounds

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.