Status:
UNKNOWN
Efficacy and Safety of Chiglitazar Added to Glargine in Patients With Type 2 Diabetes
Lead Sponsor:
Yanbing Li
Conditions:
Efficacy and Safety of Chiglitazar Sodium in the Treatment of T2DM Patients
Metformin Combined With Insulin Glargine in the Treatment of Type 2 Diabetes Patients Who Still Have Poor Hypoglycemic Effect
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate the Efficacy and Safety of Chiglitazar Added to Patients with type 2 diabetes who do not respond well to metformin combined with insulin glargine. The ma...
Detailed Description
T2DM patients using insulin combined with metformin dual therapy regimen, still can not have effective control of blood sugar, the combination of follow-up treatment and hypoglycemic drugs is worth ex...
Eligibility Criteria
Inclusion
- In accordance with the World Health Organization (WHO) issued in 1999 diabetes diagnostic criteriaType 2 diabetes mellitus (T2DM);
- 2\. Male or female patients ≥18 years old;
- 3, BMI≥18.5 Kg/m2, \< 35 Kg/m2;
- 4, Glycosylated hemoglobin (HbA1C) \> 7.5%; ≤10.5%;
- 5, Stable dose (insulin daily therapeutic dose change within ±20%) of glycerine or DI The therapeutic dose of Terterigu or NPH basal insulin is ≥0.25IU/kg/ day/or 20IU/ day；
- 6, Stable basic insulin treatment combined with metformin (metformin dose ≥1000mg/Days or maximum tolerated dose) ≥3 months；
- 7\. Voluntarily sign informed consent and agree to be randomly assigned to any experimental group.
Exclusion
- 1, Type 1 diabetes or specific type diabetes;
- 2\. Fasting blood glucose (FPG) exceeding 13.3 mmol/L (240 mg/dL);
- 3, refractory hypertension \[that is, on the basis of improving lifestyle, the application of a reasonable and tolerable sufficient amount of 3 or more antihypertensive drugs (including diuretics) for more than 1 month still does not reach the standard, or take 4 or more antihypertensive drugs to effectively control blood pressure\];
- 4\. Triglyceride (TG) \> 500 mg /dL (5.65 mmol/L);
- 5, is taking or in the last 1 month has taken fibrate drug treatment;
- 6, lower limb edema or general edema;
- 7\. Experienced 3 or more episodes of severe hypoglycemia and/or unintentional hypoglycemia in the 6 months prior to screening;
- 8\. A definite diagnosis of osteoporosis or any other known bone disease;
- 9\. History of diabetic ketoacidosis, diabetic hyperglycemia hyperosmolar syndrome, lactic acidosis and other acute complications of diabetes;
- 10\. Severe microvascular complications (proliferative retinopathy; Urinary albumin/creatinine ratio \> 300 mg/g; Marked peripheral neuropathy, etc.);
- 11\. Large vascular lesions leading to hospital admission within 6 months before inclusion;
- 12, The New York Heart Association (NYHA) defines congestive heart failure as grade III or IV
- 13, significant liver and kidney dysfunction and systemic disease (significant liver dysfunction is defined as AST\> 2.5 times the upper limit of normal and/or ALT\> 2.5 times the upper limit of normal and/or total bilirubin \> 1.5 times the upper limit of normal value; Renal dysfunction was defined as moderate to severe renal insufficiency (eGFR\<60 ml/ (min\*1.73m2)).
- 14\. Use of other hypoglycemic agents not specified in the inclusion criteria (thiazolidinediones, GLP-1RA, premixed or fast-acting insulin) in the current or 3 months prior to screening, with the exception of short-term treatment with additional insulin (a total of 7 days or less) for complications;
- 15, pregnant or lactating women, women of childbearing age who are unable or unwilling to take adequate contraception;
- 16\. Participating in clinical trials of other drugs or medical devices during or within 3 months prior to screening;
- 17\. The investigator considers it inappropriate to participate in this clinical trial.
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06007014
Start Date
October 31 2023
End Date
December 30 2025
Last Update
September 13 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
the First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510000