The Experiment of Noiiglutide Injection in Type 2 Diabetes Patients

NCT06649773 | Active Not Recruiting Phase 3

• 1 other identifier: SHR20004-302
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

  Week 26

Secondary Outcomes (15)

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

  Week 26

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

  Week 26

• Changes in fasting plasma glucose relative to baseline

  Week 26

• Changes in fasting body weight relative to baseline

  Week 26

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

  Week 26

Study Arms (2)

Noiiglutide Injection

EXPERIMENTAL

Drug: Noiiglutide Injection

Noiiglutide Placebo

PLACEBO COMPARATOR

Drug: Noiiglutide Placebo

Interventions

Noiiglutide Injection DRUG

Experimental group

Noiiglutide Injection

Noiiglutide Placebo DRUG

Placebo Comparator group

Noiiglutide Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Beijing Chaoyang Hospital Affiliated to Capital

Beijing, Beijing Municipality, 100020, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 21, 2024
• Study Start: October 25, 2024
• Primary Completion: May 28, 2025
• Study Completion: September 30, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

CN (1)