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

September 12, 2023 updated by: Yanbing Li

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • The First Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 > 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Metformin and insulin glargine combined with sitaglitat sodium tablets 48mg/ day group;
Drug: Chiglitazar sodium
tablets 48mg/ day administered for 18 weeks
Placebo Comparator: Placebo group
Metformin and insulin glargine combined with placebo group
Drug: Chiglitazar placebo
tablets 48mg/ day administered for 18 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HbA1C
Time Frame: 18 weeks of treatment
Changes in HbA1C from baseline
18 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Insulin
Time Frame: 6 weeks and 18 weeks of treatment
Changes in the daily dose of insulin from baseline
6 weeks and 18 weeks of treatment
Triglyceride
Time Frame: 18 weeks of treatment
Changes in the daily dose of triglyceride from baseline
18 weeks of treatment
Fasting blood glucose
Time Frame: 6 weeks and 18 weeks of treatment
Changes in the daily dose of fasting blood glucose from baseline
6 weeks and 18 weeks of treatment
Fasting C-Peptide
Time Frame: 18 weeks of treatment
Changes in the daily dose of fasting C-Peptide from baseline
18 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yanbing Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HLi

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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