Efficacy and Safety of Chiglitazar Sodium in the Treatment of T2DM PatientsNCT06007014

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

A study testing Chiglitazar sodium in people with Efficacy and Safety of Chiglitazar Sodium in the Treatment of T2DM Patients and Metformin Combined With Insulin Glargine in the Treatment of Type 2 Diabetes Patients Who Still Have Poor Hypoglycemic Effect, run by Yanbing Li at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: 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
What is being tested?: Chiglitazar sodium
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 128 participants
Where: 1 siteChina
Study dates: 31 Oct 2023to 30 Dec 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

the First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000

Other trials in China

About this study

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

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.

Read the 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.

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
Being tested: Chiglitazar sodium, Chiglitazar placebo
Keywords: Chiglitazar, T2DM, Randomised, Double-blind, Placebo Parallel Controlled

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chiglitazar sodiumDrug
tablets 48mg/ day administered for 18 weeks
Chiglitazar placeboDrug
tablets 48mg/ day administered for 18 weeks

Study groups in NCT06007014
Study group	Role	What they receive
Intervention group	Experimental	Metformin and insulin glargine combined with sitaglitat sodium tablets 48mg/ day group; Receives: Drug: Chiglitazar sodium
Placebo group	Placebo comparator	Metformin and insulin glargine combined with placebo group Receives: Drug: Chiglitazar placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

HbA1C
Changes in HbA1C from baseline
Measured: 18 weeks of treatment

Secondary outcomes (4)

Insulin
Changes in the daily dose of insulin from baseline
Measured: 6 weeks and 18 weeks of treatment
Triglyceride
Changes in the daily dose of triglyceride from baseline
Measured: 18 weeks of treatment
Fasting blood glucose
Changes in the daily dose of fasting blood glucose from baseline
Measured: 6 weeks and 18 weeks of treatment
Fasting C-Peptide
Changes in the daily dose of fasting C-Peptide from baseline
Measured: 18 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 202330 Dec 2025

First posted23 Aug 2023
Study start31 Oct 2023 (estimated)
Primary completion30 Oct 2025 (estimated)
Study completion30 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Efficacy and Safety of Chiglitazar Sodium in the Treatment of T2DM PatientsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Metformin and insulin glargine combined with Chiglitazar sodium tablets 48mg/ day group；Metformin and insulin glargine combined with placebo group.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 128 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06007014
Sponsor's protocol ID: HLi
Status last verified: Sep 2023
First submitted: 26 Jul 2023
Last updated: 13 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06007014
Acronym / sponsor ID: HLi
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
Keywords: Chiglitazar, T2DM, Randomised, Double-blind, Placebo Parallel Controlled
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 128 participants (estimated)
Lead sponsor: Yanbing LiUniversity, hospital or other
Study start: 31 Oct 2023 (estimated)
Primary completion: 30 Oct 2025 (estimated)
Study completion: 30 Dec 2025 (estimated)
First posted: 23 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Metformin and insulin glargine combined with Chiglitazar sodium tablets 48mg/ day group；Metformin and insulin glargine combined with placebo group.

Arm	Type	Receives
Intervention group	Experimental	Drug: Chiglitazar sodiumMetformin and insulin glargine combined with sitaglitat sodium tablets 48mg/ day group;
Placebo group	Placebo comparator	Drug: Chiglitazar placeboMetformin and insulin glargine combined with placebo group

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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；

Key exclusion criteria (17 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Chiglitazar sodiumtablets 48mg/ day administered for 18 weeks	Drug	Intervention group
Chiglitazar placebotablets 48mg/ day administered for 18 weeks	Drug	Placebo group

Primary outcome

HbA1C
Time frame: 18 weeks of treatment
Changes in HbA1C from baseline

4 secondary outcomes

Insulin
Time frame: 6 weeks and 18 weeks of treatment
Triglyceride
Time frame: 18 weeks of treatment
Fasting blood glucose
Time frame: 6 weeks and 18 weeks of treatment
Fasting C-Peptide
Time frame: 18 weeks of treatment

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1C (time frame: 18 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06007014.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.