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Efficacy of smaglutide in combination with intensive lifestyle intervention/chiglitazar sodium in remission of type 2 diabetes and non-alcoholic fatty liver disease

Efficacy of smaglutide in combination with intensive lifestyle intervention/chiglitazar sodium in remission of type 2 diabetes and non-alcoholic fatty liver disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064171
Enrollment
Unknown
Registered
2022-09-28
Start date
2022-09-30
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetic mellitus

Interventions

Study group:smaglutide
Study group:Intensive Lifestyle Intervention
Control Group:metformin
Control Group:Intensive Lifestyle Intervention
Study group :chiglitazar

Sponsors

Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female aged 20-70 years with BMI >= 25 kg/m2; 2. Diagnosed with type 2 diabetes within 6 years; 3. During screening, HbA1c >= 6.5% and <= 10% in the absence of hypoglycemic drugs or <= 10% in metformin monotherapy; 4. Be able and willing to sign written informed consent and abide by the study protocol.

Exclusion criteria

Exclusion criteria: 1. Within 3 months before signing informed consent, the researchers assessed the following cardiovascular diseases: myocardial infarction, cardiac surgery, or angioplasty or percutaneous coronary angioplasty (coronary artery bypass grafting), unstable angina pectoris, heart failure, unstable New York heart association (NYHA) class IV for congestive heart failure, transient ischemic attack or severe cerebrovascular disease, unstable or before diagnosis of arrhythmia; 2. Received any other hypoglycemic agents other than metformin during the 30 days prior to enrollment or during the 5 study drug half-lives; 3. Weight loss of more than 5kg within 6 months; 4. Pregnant women with positive pregnancy tests, women who wished to become pregnant during the study period, women who were breastfeeding, or women of childbearing age did not use a highly effective and medically proven method of contraception; 5. History of acute complications of diabetes within 30 days (e.g., ketoacidosis, hyperglycemic hyperotonic state) or diabetes insipidus; 6. A history of alcohol, drug abuse or other conditions that may reduce study or medication compliance within 3 months; 7. Within 30 days prior to the use of the drug in this study, they had taken the study drug in another clinical trial or participated in another clinical trial (receiving drug intervention or during the follow-up observation period); 8. Clinically significant liver biliary system diseases, such as chronic active hepatitis with/without severe liver insufficiency. ALT or AST > 3 times the upper limit of normal, or total bilirubin > 34.2 µmol/L( > 2 mg/dL); 9. Severe renal impairment or end-stage renal disease (eGFR < 45 mL/min/1.73 m2); 10. Had bariatric surgery or other gastrointestinal surgery within 2 years that resulted in chronic malabsorption; 11. Had a history of malignant tumor or thyroid cancer within 5 years of the visit; 12. Known immunodeficiency, such as organ transplant or acquired immune deficiency syndrome (AIDS) diagnosis; 13. A history of secondary fractures due to severe osteoporosis; 14. Signed informed consent. Is currently receiving systemic steroid therapy, or has adjusted thyroid hormone medication within 6 weeks, or has an uncontrolled endocrine disease other than type 2 diabetes; 15. Patients were treated with sibutramine, phentermine, orlistat, rimonabant, benzyfatamine, amphiradone, methylamphetamine, and benzometholine within 30 days of follow-up; 16. Currently (or in the past 3 months) participating in an organized weight loss program; 17. Malignant diseases of the blood system or other diseases causing lysis or destruction of red blood cells (e.g., malaria, babesiosis); 18. Take any other study drug within 30 days prior to enrollment or during 5 study drug half-lives. 19. In the investigator's judgment, subjects are unable to comply with the study protocol requirements or have any serious medical or psychiatric condition that could affect the evaluation of efficacy and safety data.

Design outcomes

Primary

MeasureTime frame
Glycosylated hemoglobin;

Countries

China

Contacts

Public ContactXu Yong

Affiliated Hospital of Southwest Medical University

xywyll@aliyun.com+86 13980255895

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026