Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes

What Was Tested

This registered phase 3 trial tested Insulin Aspart.

Poor blood glucose control in liver cirrhosis can aggravate the poor prognosis of patients.

The traditional treatment of diabetes at the stage of liver cirrhosis is limited to insulin intensive therapy, but the incidence of hypoglycemia is high, blood sugar fluctuates greatly, and multiple injections are required.

It had two arms (groups): group with new combination therapy (experimental) and group with intensive insulin therapy (active comparator).

The registry classes the interventions as drug.

More on the Plan

It has a special pathophysiological mechanism that liver factors participate in blood glucose regulation.

The researchers used metformin, ,Ryzodeg and an oral DDP IV enzyme inhibitor as the core combination according to the special pathological mechanism of elevated blood glucose in liver cirrhosis from multiple links.

Who Took Part

Enrollment: 184 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Age 18-70 years. Patients with elevated blood sugar who meet the diabetes standard or have been treated with hypoglycemic drugs.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: those unwilling to participate or unable to cooperate;; child-pugh score is greater than 12;; patients with cardiac insufficiency;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

The Insulin Aspart group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2022-10-01 with completion listed for 2025-12-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: time in range (time frame: two weeks). Blood lactic acid level (time frame: two week). Compound adverse events (time frame: two week).

It also tracked 9 secondary outcomes, for example mean blood glucose, Time above range, Time below range, Blood lactic acid, Glycated Albumin and three month mortality.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 184 people.

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

More context: the Insulin Aspart compound page, all human trials.