Efficacy and Safety of Chiglitazar Added to Glargine in Patients With Type 2 Diabetes

NCT06007014 | Unknown

• 1 other identifier: HLi
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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 main question it aims to answer are: • T2DM patients still cannot effectively control their blood sugar with the combination of insulin and metformin. The combination of follow-up treatment and hypoglycemic drugs is worth exploring, and it is necessary to explore and confirm the combination of effective and safe drugs for insulin resistance on the basis of the above treatment plans. Participants will be asked to receive either Chiglitazar or placebo in addition to metformin and insulin glargine 18 weeks. Researchers will compare placebo groups to see if the effective effect and safety indicators of Chiglitazar for reducing insulin dosage, lowering blood sugar, regulating blood lipids.

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; 128 Patients Were Randomly Assigned 1:1; Metformin and Insulin Glargine Combined With Chiglitazar Sodium Tablets 48mg/ Day Group; Metformin and Insulin Glargine Combined With Placebo Group; InvestigatorInitiate Trial; Changes in HbA1C From Baseline at 18 Weeks of Treatment

Keywords

Chiglitazar; T2DM; Randomised; Double-blind; Placebo Parallel Controlled

Outcome Measures

Primary Outcomes (1)

• HbA1C

  Changes in HbA1C from baseline

  18 weeks of treatment

Secondary Outcomes (4)

• Insulin

  6 weeks and 18 weeks of treatment

• Triglyceride

  18 weeks of treatment

• Fasting blood glucose

  6 weeks and 18 weeks of treatment

• Fasting C-Peptide

  18 weeks of treatment

Study Arms (2)

Intervention group

EXPERIMENTAL

Metformin and insulin glargine combined with sitaglitat sodium tablets 48mg/ day group;

Drug: Chiglitazar sodium

Placebo group

PLACEBO COMPARATOR

Metformin and insulin glargine combined with placebo group

Drug: Chiglitazar placebo

Interventions

Chiglitazar sodium DRUG

tablets 48mg/ day administered for 18 weeks

Intervention group

Chiglitazar placebo DRUG

tablets 48mg/ day administered for 18 weeks

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In accordance with the World Health Organization (WHO) issued in 1999 diabetes diagnostic criteriaType 2 diabetes mellitus (T2DM);
• \. Male or female patients ≥18 years old;
• , BMI≥18.5 Kg/m2, \< 35 Kg/m2;
• , Glycosylated hemoglobin (HbA1C) \> 7.5%; ≤10.5%;
• , 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；
• , Stable basic insulin treatment combined with metformin (metformin dose ≥1000mg/Days or maximum tolerated dose) ≥3 months；
• \. Voluntarily sign informed consent and agree to be randomly assigned to any experimental group.

You may not qualify if:

• , Type 1 diabetes or specific type diabetes;
• \. Fasting blood glucose (FPG) exceeding 13.3 mmol/L (240 mg/dL);
• , refractory hypertension \[that is, on the basis of improving lifestyle, the application of a reasonable and tolerable sufficient amount of 3 or more antihypertensive drugs (including diuretics) for more than 1 month still does not reach the standard, or take 4 or more antihypertensive drugs to effectively control blood pressure\];
• \. Triglyceride (TG) \> 500 mg /dL (5.65 mmol/L);
• , is taking or in the last 1 month has taken fibrate drug treatment;
• , lower limb edema or general edema;
• \. Experienced 3 or more episodes of severe hypoglycemia and/or unintentional hypoglycemia in the 6 months prior to screening;
• \. A definite diagnosis of osteoporosis or any other known bone disease;
• \. History of diabetic ketoacidosis, diabetic hyperglycemia hyperosmolar syndrome, lactic acidosis and other acute complications of diabetes;
• \. Severe microvascular complications (proliferative retinopathy; Urinary albumin/creatinine ratio \&gt; 300 mg/g; Marked peripheral neuropathy, etc.);
• , The New York Heart Association (NYHA) defines congestive heart failure as grade III or IV
• , significant liver and kidney dysfunction and systemic disease (significant liver dysfunction is defined as AST\&gt; 2.5 times the upper limit of normal and/or ALT\&gt; 2.5 times the upper limit of normal and/or total bilirubin \&gt; 1.5 times the upper limit of normal value; Renal dysfunction was defined as moderate to severe renal insufficiency (eGFR\&lt;60 ml/ (min\*1.73m2)).
• , pregnant or lactating women, women of childbearing age who are unable or unwilling to take adequate contraception;
• \. Participating in clinical trials of other drugs or medical devices during or within 3 months prior to screening;
• \. The investigator considers it inappropriate to participate in this clinical trial.

Sponsors & Collaborators

• Yanbing Li: lead

Study Sites (1)

the First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Metformin and insulin glargine combined with Chiglitazar sodium tablets 48mg/ day group；Metformin and insulin glargine combined with placebo group.

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 23, 2023
• Study Start: October 31, 2023
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

CN (1)