The Experiment of Noiiglutide Injection in Type 2 Diabetes Patients (NCT06649773) | Clinical Trial Compass
Active — Not RecruitingPhase 3
The Experiment of Noiiglutide Injection in Type 2 Diabetes Patients
China137 participantsStarted 2024-10-25
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. The researchers suspect that the subjects may be allergic to the investigational drug;
✕
What they're measuring
1
Changes in glycated hemoglobin (HbA1c) relative to baseline at week 24 in SHR20004 compared to placebo.
. 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;