NCT05641337

Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes

Status unknown Phase 3 Last updated 7 December 2022

What this trial tests

Phase 3 trial testing Insulin Degludec and Insulin Aspart in Liver Cirrhosis in 184 participants. Status unknown.

Timeline

1 October 2022

Primary endpoint
30 December 2025

30 December 2025

Quick facts

Lead sponsor	Huashan Hospital
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	184
Start date	1 October 2022
Primary completion	30 December 2025
Estimated completion	30 December 2025
Sites	1 location across China

Drugs / interventions tested

• Insulin Degludec and Insulin Aspart — full drug profile →

Conditions studied

• Liver Cirrhosis — all drugs for Liver Cirrhosis →
• Diabetes — all drugs for Diabetes →

Sponsor

Huashan Hospital

Who can join

Adults 18 to 70, any sex, with Liver Cirrhosis or Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Poor blood glucose control in liver cirrhosis can aggravate the poor prognosis of patients. Under the background of the increasing number of liver cirrhosis patients with metabolic abnormalities, how to optimize treatment is particularly important. 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. Research shows that insulin therapy has an increased overall mortality compared with non insulin therapy. We 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 . After preliminary experiments, we found that the program was stable and was not easy to have hypoglycemia, and there was no traditional risk of lactic acid poisoning caused by metformin. We designed an open randomized controlled clinical study, Compared with the traditional insulin intensive treatment scheme, this new combination scheme was compared whether it could improve the blood glucose level, the incidence of hypoglycemia and lactic acid level, the incidence of cirrhosis complications, and the long-term survival rate of liver disease. This study is helpful to optimize the hypoglycemic treatment of cirrhosis with diabetes, and improve the blood glucose and long-term prognosis, The positive evidence of this study contributes to the consensus or guidelines for the treatment of cirrhosis with diabetes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.