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Type 2 DiabetesPhase 3NCT06649773

The Experiment of Noiiglutide Injection in Type 2 Diabetes Patients

A Phase 3 study testing Noiiglutide Injection in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to confirm that SHR20004 is more effective than placebo in controlling blood glucose in patients with type 2 diabetes. Evaluate the efficacy, safety, and pharmacokinetics of SHR20004 after 24 weeks of treatment. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Noiiglutide Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
137 participants
Where
1 siteChina
Study dates
6 Nov 2024to 11 Dec 2025
Phase
Phase 3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, on the day of signing the informed consent form, aged between 18 and 75 years old;
  • During screening, according to the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Type 2 diabetes (2020 Edition), T2DM has a history of ≥ 3 months;
  • When screening, 7.5% ≤ HbA1c ≤ 10.0% (tested by local laboratory);
  • When filtering, 1) Metformin monotherapy for stable treatment for ≥ 3 months and daily dose ≥ 1500 mg or maximum tolerated dose (≥ 1000 mg); Or 2) Metformin combined with another domestically approved oral hypoglycemic drug for stable treatment for ≥ 3 months. Metformin is administered at the aforementioned dose, while the dose of the other oral hypoglycemic drug is ≥ half of the maximum approved dose or the maximum tolerated dose as indicated in the instructions. Another type of oral hypoglycemic drug must exclude drugs containing GLP-1 RA components (including multi-target drugs) and DPP-4 inhibitors;
  • When screening, 19.0 kg/m2 ≤ Body Mass Index (BMI) ≤ 45.0 kg/m2;
  • Capable and willing to comply with the protocol, including self-monitoring of blood glucose, recording participant diaries, and using pre filled injection pens;
  • From the signing of the informed consent form until 2 weeks after the last administration, the subject (including partner) has no plans to have children and is willing to use the high-efficiency contraceptive measures specified in the protocol.

Who cannot join

  • The researchers suspect that the subjects may be allergic to the investigational drug;
  • Discontinuation of GLP-1 RA treatment due to safety/tolerability reasons or lack of effectiveness reasons in the past (excluding cases where GLP-1 RA is discontinued due to non efficacy or non safety reasons such as economic reasons, and no GLP-1 RA has been used within the past 3 months before screening);
  • Before screening, any of the following drugs or treatments were used:
  • Have participated in any clinical trial of a drug within the first 3 months or 5 half lives (whichever is longer) before screening (has entered the randomization phase);
  • Within 3 months, there has been drug or alcohol abuse that, according to the researcher's judgment, may affect the participation or status of the subjects in the trial, resulting in an impact on the use of trial drugs or compliance during the trial process;
  • Screening for long-term (continuous 7 days or more) intravenous or oral administration of corticosteroids received within the previous 3 months;
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  • Within the first 3 months of screening, individuals who have used drugs with weight control effects, undergone surgeries that can cause weight instability, or experienced significant changes in weight (with a difference of ≥ 5 kg between maximum and minimum weight), or are currently on a weight loss plan and not in the maintenance phase;
  • According to the researchers' judgment, any drug that may interfere with the interpretation of efficacy and safety data, or any drug known to have common toxic reactions to major organs, has been used within the previous month before screening;
  • History or evidence of any of the following diseases before screening:
  • Type 1 diabetes, diabetes with single gene mutation, diabetes caused by pancreatic injury or other secondary diabetes, such as diabetes caused by Cushing's syndrome or acromegaly;
  • There are high-risk factors that may lead to pancreatitis, such as a history of acute or chronic pancreatitis, a history of symptomatic gallbladder disease (excluding post cholecystectomy), and a history of pancreatic injury;
  • A personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2;
  • There is a clinically relevant history of gastrointestinal disorders, accompanied by persistent nausea and vomiting, including but not limited to: gastroesophageal reflux disease with gastroparesis within the 6 months prior to screening, requiring treatment, unstable (worsening) or poorly controlled (persistent nausea and vomiting); Surgical history that may affect gastric emptying;
  • Screening for severe hypoglycemic events or recurrent hypoglycemic events within the previous 6 months (≥ 3 hypoglycemic events within a week, or other hypoglycemic events determined by the researcher);
  • Having obvious hematological disorders (such as aplastic anemia, myelodysplastic syndrome) or any disease that causes hemolysis or red blood cell instability (such as malaria);
  • There are serious chronic complications of diabetes or there is a risk of acute complications within 6 months, and the investigator believes that it is not suitable to participate in this trial;
  • Any organ system malignant tumor that has been treated or not treated within 5 years, regardless of evidence of local recurrence or metastasis, except for local basal cell carcinoma of the skin;
  • Suffering from cardiovascular disease, defined as: having congestive heart failure (NYHA III-IV), unstable angina, stroke, myocardial infarction, or coronary revascularization within the first 6 months of screening; Plan to undergo coronary artery, carotid artery, or peripheral artery revascularization during screening;
  • Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg;
  • There is a history of thyroid disease that cannot be controlled with stable drug dosage, and it has been determined by the researchers to affect the safety or efficacy of the subjects;
  • Serious trauma or infection that may affect blood sugar control has occurred within one month;
  • During screening, laboratory tests showed the following situations:
  • Fasting venous glucose ≥ 13.9 mmol/L;
  • Serum amylase and/or serum lipase>3 times the upper limit of normal (ULN);
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>3 × ULN;
  • Moderate (3b) or severe renal failure or renal insufficiency (estimated glomerular filtration rate [eGFR] calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula<45 mL/min/1.73 m2) or in compliance with contraindications for metformin;
  • Urinary albumin/creatinine ratio (UACR) ≥ 300 mg/g;
  • Total bilirubin>2.0 × ULN;
  • Calcitonin ≥ 50 ng/L;
  • Triglycerides ≥ 5.7 mmol/L.
  • Abnormal 12 lead electrocardiograms with clinical significance during screening, such as grade II or III atrioventricular block (excluding right bundle branch block), long QT syndrome or QTc>500 ms, severe arrhythmia, etc. (mild T wave and ST segment changes may not be ruled out if the researcher judges that the subject's clinical symptoms are not obvious) in the absence of a pacemaker;
  • Within the first 4 weeks of screening, the amount of blood donated or lost is ≥ 400 mL, or a blood transfusion has been received;
  • Pregnant or lactating women, as well as fertile men or women who are unwilling to use contraception during the study period;
  • The researchers believe that the subjects have any other factors that may affect the efficacy or safety evaluation of this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Chaoyang Hospital Affiliated to Capital

    Beijing, Beijing Municipality, 100020

Other trials in China

About this study

Official title: A Study to Evaluate the Efficacy and Safety of Noiiglutide Injection in Type 2 Diabetes Patients Who Received Metformin in Combination With or Without Another Oral Hypoglycemic Drug for Poor Blood Glucose Control -- a Phase III Clinical Trial of Multicenter, Randomized, Double-blind, Placebo Parallel Control

This study aims to confirm that SHR20004 is more effective than placebo in controlling blood glucose in patients with type 2 diabetes. Evaluate the efficacy, safety, and pharmacokinetics of SHR20004 after 24 weeks of treatment.

Conditions
Type 2 Diabetes
Being tested
Noiiglutide Injection, Noiiglutide Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Noiiglutide InjectionDrug

    Experimental group

  • Noiiglutide PlaceboDrug

    Placebo Comparator group

Study groups in NCT06649773
Study groupRoleWhat they receive
Noiiglutide InjectionExperimentalNot described
Receives: Drug: Noiiglutide Injection
Noiiglutide PlaceboPlacebo comparatorNot described
Receives: Drug: Noiiglutide Placebo

What is being measured

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

  1. Changes in glycated hemoglobin (HbA1c) relative to baseline at week 24 in SHR20004 compared to placebo.

    Measured: Week 26

Secondary outcomes (15)

  1. The proportion of subjects who achieve the HbA1c target value (<7.0%)

    Measured: Week 26

  2. The proportion of subjects who achieve the HbA1c target value (≤ 6.5%)

    Measured: Week 26

  3. Changes in fasting plasma glucose relative to baseline

    Measured: Week 26

  4. Changes in fasting body weight relative to baseline

    Measured: Week 26

  5. Changes in plasma glucose levels relative to baseline 2 hours after meals

    Measured: Week 26

  6. 7-point self-test of blood glucose (SMBG) spectrum relative to baseline changes

    Measured: Week 26

  7. Changes in blood pressure relative to baseline

    Measured: Week 26

  8. Changes in fasting insulin relative to baseline

    Measured: Week 26

  9. Changes in C-peptide relative to baseline

    Measured: Week 26

  10. Changes in insulin levels relative to baseline 2 hours after meals

    Measured: Week 26

  11. Changes in C-peptide levels relative to baseline 2 hours after meals

    Measured: Week 26

  12. Adverse events (AE)

    Measured: Week 26

  13. ADA of SHR20004

    Measured: Week 26

  14. Nab of SHR20004

    Measured: Week 26

  15. The concentration of SHR20004 in plasma at steady state

    Measured: Week 26

Timeline

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

  1. First posted21 Oct 2024
  2. Study start6 Nov 2024
  3. Primary completion28 May 2025
  4. Study completion11 Dec 2025

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06649773
Sponsor's protocol ID
SHR20004-302
Status last verified
Aug 2026
First submitted
8 Oct 2024
Last updated
25 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Noiiglutide Injection in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

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 34 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: finished, as of the sponsor's last update on 25 Aug 2026. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Changes in glycated hemoglobin (HbA1c) relative to baseline at week 24 in SHR20004 compared to placebo. (time frame: Week 26). 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 NCT06649773.

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 25 Aug 2026.

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