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

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chiglitazar sodium
Chiglitazar placebo
Sponsored by
Yanbing Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Efficacy and Safety of Chiglitazar Sodium in the Treatment of T2DM Patients focused on measuring Chiglitazar, T2DM, Randomised, Double-blind, Placebo Parallel Controlled

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1.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 Criteria: 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 &gt; 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&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)). 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.

Sites / Locations

  • the First Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Placebo group

Arm Description

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

Metformin and insulin glargine combined with placebo group

Outcomes

Primary Outcome Measures

HbA1C
Changes in HbA1C from baseline

Secondary Outcome Measures

Insulin
Changes in the daily dose of insulin from baseline
Triglyceride
Changes in the daily dose of triglyceride from baseline
Fasting blood glucose
Changes in the daily dose of fasting blood glucose from baseline
Fasting C-Peptide
Changes in the daily dose of fasting C-Peptide from baseline

Full Information

First Posted
July 26, 2023
Last Updated
September 12, 2023
Sponsor
Yanbing Li
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1. Study Identification

Unique Protocol Identification Number
NCT06007014
Brief Title
Efficacy and Safety of Chiglitazar Added to Glargine in Patients With Type 2 Diabetes
Official Title
A Multi-Center, Randomised, Double-blind, Placebo Parallel Controlled Clinical Study to Evaluate the Efficacy and Safety of Chiglitazar Added to Glargine in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
October 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yanbing Li

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 exploring, and it is necessary to base on the above treatment plans to explore and confirm the treatment of effective and safe drugs for insulin resistance. This study investigated the efficacy and safety of metformin combined with insulin glargine in the treatment of type 2 diabetes mellitus (T2DM) in patients who still have poor hypoglycemic effect, plus Chiglitazar 48mg/ day for 18 weeks. A total of 128 patients were expected to be included, and were randomly assigned 1:1 to the combination of metformin and insulin glargine combined with Chiglitazar sodium tablet 48mg/ day group. Metformin and insulin glargine combined with placebo group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Metformin and insulin glargine combined with Chiglitazar sodium tablets 48mg/ day group;Metformin and insulin glargine combined with placebo group.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Metformin and insulin glargine combined with sitaglitat sodium tablets 48mg/ day group;
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Metformin and insulin glargine combined with placebo group
Intervention Type
Drug
Intervention Name(s)
Chiglitazar sodium
Intervention Description
tablets 48mg/ day administered for 18 weeks
Intervention Type
Drug
Intervention Name(s)
Chiglitazar placebo
Intervention Description
tablets 48mg/ day administered for 18 weeks
Primary Outcome Measure Information:
Title
HbA1C
Description
Changes in HbA1C from baseline
Time Frame
18 weeks of treatment
Secondary Outcome Measure Information:
Title
Insulin
Description
Changes in the daily dose of insulin from baseline
Time Frame
6 weeks and 18 weeks of treatment
Title
Triglyceride
Description
Changes in the daily dose of triglyceride from baseline
Time Frame
18 weeks of treatment
Title
Fasting blood glucose
Description
Changes in the daily dose of fasting blood glucose from baseline
Time Frame
6 weeks and 18 weeks of treatment
Title
Fasting C-Peptide
Description
Changes in the daily dose of fasting C-Peptide from baseline
Time Frame
18 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.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 Criteria: 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 &gt; 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&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)). 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.
Facility Information:
Facility Name
the First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

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

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