Liver CirrhosisPhase 3NCT05641337
Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes
A Phase 3 study testing Insulin Degludec and Insulin Aspart in people with Liver Cirrhosis and Diabetes, run by Huashan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cirrhosis, Diabetes
- What is being tested?
- Insulin Degludec and Insulin Aspart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 30 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver cirrhosis
- Age 18-70 years
- Patients with elevated blood sugar who meet the diabetes standard or have been treated with hypoglycemic drugs
- random finger or venous serum blood glucose more than 14 mmol/L
Who cannot join
- Those unwilling to participate or unable to cooperate;
- Child-pugh score is greater than 12;
- Glomerular filtration rate<60ml/min/1.73m2;
- Patients with cardiac insufficiency;
- Patients with asymptomatic hypoglycemia;
- Pregnant patients were excluded;
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- Patients with advanced liver cancer;
- Blood pressure is less than 90/60mmHg;
- Chronic liver disease plus acute or subacute liver failure;
- Patients with drug induced blood glucose disorder, such as glucocorticoids, contraceptives, etc;
- fingertip oxygen saturation less than 95% without oxygen inhalation;
- Autoimmune liver cirrhosis is currently taking hormone.
- Type 1 diabetes.
- Pancreatogenic diabetes, such as primary hemochromatosis, hepatolenticular degeneration, alcoholic pancreatitis, autoimmune diseases involving the pancreas, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiaolong Zhao
Shanghai, Shanghai Municipality, 200041
Xiaolong Zhao, PhD, 13501827230, xiaolongzhao@163.com
Duoduo Qu, master, 19852812469, quduoduonju@163.com
About this study
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.
Read the detailed description
Cirrhosis with diabetes refers to the increase of blood sugar in cirrhosis, including cirrhosis before or after diabetes. It has a special pathophysiological mechanism that liver factors participate in blood glucose regulation. 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 from multiple links. 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 of such patients, The positive evidence of this study contributes to the consensus or guidelines for the treatment of cirrhosis with diabetes.
- Conditions
- Liver Cirrhosis, Diabetes
- Being tested
- Insulin Degludec and Insulin Aspart
- Keywords
- Liver cirrhosis, diabetes, time in range, insulin intensive therapy, new combination therapy
- Medical subject headings
- Liver Cirrhosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Degludec and Insulin AspartDrug
Also called metformin, linagliptin
The hypoglycemic scheme of the experimental group was that the initial dose of Insulin Degludec and Insulin Aspart was 0.3U/kg multiplied by the patient's weight, plus 5 mg of linagliptin and 0.5 g of metformin three times a day. The control group was treated with traditional four needle insulin.
| Study group | Role | What they receive |
|---|---|---|
| group with new combination therapy | Experimental | The hypoglycemic scheme of the experimental group was that the initial dose of Insulin Degludec and Insulin Aspart was 0.3U/kg multiplied by the patient's weight, plus 5 mg of linagliptin and 0.5 g of metformin three times a day. Receives: Drug: Insulin Degludec and Insulin Aspart |
| group with intensive insulin therapy | Active comparator | group was treated with intensive insulin therapy.The initial total amount of insulin is 0.5U/kg, of which 40% is basal insulin and 20% is aspart insulin before three meals Receives: Drug: Insulin Degludec and Insulin Aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
time in range
time in range
Measured: two weeks
Blood lactic acid level
Blood lactic acid level
Measured: two week
Compound adverse events
includetimes of hypolgycemia attack，severe hypoglycemia attack and serum lactic acid more than 2.2 mmol/L, complications of liver cirrhosis within two week
Measured: two week
Secondary outcomes (9)
mean blood glucose
mean blood glucose
Measured: two weeks
Time above range
Time above range
Measured: two weeks
Time below range
Time below range
Measured: two weeks
Blood lactic acid
Blood lactic acid
Measured: two weeks
Glycated Albumin
Glycated Albumin
Measured: two week
three month mortality
three month mortality
Measured: three months
Six month mortality
Six month mortality
Measured: six months
Incidence rate of complications of liver cirrhosis within three months
Incidence rate of complications of liver cirrhosis within three months
Measured: three months
Incidence rate of complications of liver cirrhosis within six months
Incidence rate of complications of liver cirrhosis within six months
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Oct 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiaolong zhao, Huashan Hospital
- Investigators
- Xiaolong Zhao, PhD, Study chair, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641337
- Sponsor's protocol ID
- 2022-10-cirrhosis with DM
- Status last verified
- Nov 2022
- First submitted
- 6 Nov 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes
- ClinicalTrials.gov ID
- NCT05641337
- Acronym / sponsor ID
- 2022-10-cirrhosis with DM
- Conditions
- Liver Cirrhosis, Diabetes
- Keywords
- Liver cirrhosis, diabetes, time in range, insulin intensive therapy, new combination therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cirrhosis with diabetes refers to the increase of blood sugar in cirrhosis, including cirrhosis before or after diabetes. It has a special pathophysiological mechanism that liver factors participate in blood glucose regulation. 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 from multiple links. 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 of such patients, The positive evidence of this study contributes to the consensus or guidelines for the treatment of cirrhosis with diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group with new combination therapy | Experimental | Drug: Insulin Degludec and Insulin AspartThe hypoglycemic scheme of the experimental group was that the initial dose of Insulin Degludec and Insulin Aspart was 0.3U/kg multiplied by the patient's weight, plus 5 mg of linagliptin and 0.5 g of metformin three times a day. |
| group with intensive insulin therapy | Active comparator | Drug: Insulin Degludec and Insulin Aspartgroup was treated with intensive insulin therapy.The initial total amount of insulin is 0.5U/kg, of which 40% is basal insulin and 20% is aspart insulin before three meals |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Liver cirrhosis
- Age 18-70 years
- Patients with elevated blood sugar who meet the diabetes standard or have been treated with hypoglycemic drugs
- random finger or venous serum blood glucose more than 14 mmol/L
Key exclusion criteria (14 listed)
- Those unwilling to participate or unable to cooperate;
- Child-pugh score is greater than 12;
- Glomerular filtration rate<60ml/min/1.73m2;
- Patients with cardiac insufficiency;
- Patients with asymptomatic hypoglycemia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin Degludec and Insulin AspartAlso: metformin, linagliptinThe hypoglycemic scheme of the experimental group was that the initial dose of Insulin Degludec and Insulin Aspart was 0.3U/kg multiplied by the patient's weight, plus 5 mg of linagliptin and 0.5 g of metformin three times a day. The control group was treated with traditional four needle insulin. | Drug | group with intensive insulin therapy, group with new combination therapy |
Primary outcome
time in range
Time frame: two weeks
time in range
Blood lactic acid level
Time frame: two week
Blood lactic acid level
Compound adverse events
Time frame: two week
includetimes of hypolgycemia attack，severe hypoglycemia attack and serum lactic acid more than 2.2 mmol/L, complications of liver cirrhosis within two week
9 secondary outcomes
mean blood glucose
Time frame: two weeks
Time above range
Time frame: two weeks
Time below range
Time frame: two weeks
Blood lactic acid
Time frame: two weeks
Glycated Albumin
Time frame: two week
three month mortality
Time frame: three months
Six month mortality
Time frame: six months
Incidence rate of complications of liver cirrhosis within three months
Time frame: three months
Incidence rate of complications of liver cirrhosis within six months
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaolong Zhao, PhD study chair
Shanghai Public Health Clinical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin Degludec and Insulin Aspart in people with Liver Cirrhosis and Diabetes, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaolong Zhao, PhD (13501827230, xiaolongzhao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time in range (time frame: two weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022; AzTrials last refreshed its copy on 8 Nov 2026.