Type 2 Diabetes Mellitus - Poor ControlPhase 3NCT07058545
A Study of CJC-1134-PC Injection in Antidiabetic Treatment-naive Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
A Phase 3 study testing CJC-1134-PC Injection in people with Type 2 Diabetes Mellitus - Poor Control, run by Changshan ConjuChem BioPharmaceutical Research and Development (Hebei) Co., Ltd. at 1 site in China.
Trial summary
This study is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of CJC-1134-PC Injection Administered Once Weekly in Antidiabetic Treatment-naive Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus - Poor Control
- What is being tested?
- CJC-1134-PC Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 474 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2021to 20 Feb 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects were eligible for the study only if all the following inclusion criteria were met:
- Males or females aged 18 - 70 years (inclusive) at screening;
- Subjects with body mass index (BMI) ≥ 20 kg/ m2 and ≤ 40 kg/ m2.
- Subjects diagnosed with type 2 diabetes mellitus according to 1999 World Health Organization (WHO) criteria;
- Subjects who had not received anti-diabetic therapy (including oral and injectable drugs, Chinese herbs for hypoglycemic purposes, and investigational anti-diabetic products, etc.) within 3 months prior to screening and had used anti-diabetic drugs for no more than 2 weeks since diagnosis;
- Subjects with a stable lifestyle prior to screening, e.g. no significant changes in diets and physical exercise;
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- Subjects with fasting plasma glucose (FPG) or fasting serum glucose ≤13.9 mmol/L (250 mg/dL) at screening as determined by the local laboratory (study center) and FPG≤13.9 mmol/L (250 mg/dL) as determined by the central laboratory;
- Subjects with HbA1c levels ≥ 7.0% and ≤ 11.0% at screening as determined by the local laboratory (study center), and HbA1C ≥ 7.0% and ≤ 11.0% as determined by the central laboratory;
- Patients who were able to understand the procedures and methods of the study, willing to strictly comply with the clinical trial protocol, and voluntarily signed an informed consent form (ICF).
Who cannot join
- Subjects were not eligible for the study if they met any of the following criteria:
- Prior and concomitant diseases
- Diagnosed as type 1 diabetes mellitus, diabetes mellitus due to pancreatic injury, or secondary diabetes mellitus caused by other diseases (e.g., acromegaly or Cushing syndrome);
- History of acute and chronic pancreatitis prior to screening or current history of acute and chronic pancreatitis;
- Presence of active gallbladder or biliary tract disease within 1 year prior to screening (active means presence of relevant symptoms);
- Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (family refers to first-degree blood relatives);
Show all 37Show fewer
- Presence of malignant tumors in the past 5 years (except for cured skin basal cell carcinoma and carcinoma in situ of cervix).
- Decompensated cardiac insufficiency (New York Heart Association class III or IV) either within the 6 months prior to screening or currently;
- History of myocardial infarction, coronary artery bypass grafting, coronary stenting, haemorrhagic or ischaemic stroke (except lacunar cerebral infarction), or hospitalisation for unstable angina pectoris or transient ischaemic attack within 6 months prior to screening;
- Uncontrolled and severe arrhythmia [e.g., degree II or III AV block, prolonged QT interval (QTc > 450 ms)] within 6 months prior to screening and judged by the investigator to be unsuitable for participation in this trial;
- Severe diabetic neuropathy within 6 months prior to screening;
- Proliferative diabetic retinopathy diagnosed within 6 months before or at the time of screening, either confirmed by non-mydriatic fundus photography or by pharmacologically dilated fundus examination performed by an ophthalmic healthcare provider (unless contraindicated), or with a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to screening;
- Diabetic ketoacidosis or hyperglycemic hyperosmolar state occurring within 6 months prior to screening and up to randomization;
- Previous major gastric-related surgery (e.g., major or total gastrectomy, sleeve gastrectomy, gastric bypass), current history of significant gastrointestinal conditions (such as active ulcers, gastroparesis, pyloric obstruction, intestinal obstruction, inflammatory bowel disease, etc.), or chronic gastrointestinal diseases requiring prolonged use of medications that directly affect gastrointestinal motility and are deemed unsuitable for participation in this trial by the investigator;
- Severe trauma or major surgery occurring within 1 month prior to screening up to randomization, or the systemic use of antimicrobial agents, as determined by the investigator, which may potentially impact blood glucose control; Prohibited therapies and/or drugs
- Subjects who were using weight-loss drugs, and those with significant changes (at least 10%) in body weight 3 months prior to screening;
- Subjects who received treatment with any other investigational drug or device within 3 months prior to screening;
- Subjects who received treatment with systemic glucocorticoids (other than inhaled or topical glucocorticoids) or growth hormone within 3 months prior to screening;
- Subjects who were using warfarin at the time of screening and were unable to discontinue it for the duration of the study; Laboratory results
- Systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg after 5 minutes of sedentary rest at the time of screening or on the day of randomization [if the above criteria were not met, the test could be repeated twice (each time more than 1 minute apart), and the average of the three tests could be used to assess against the aforementioned criteria again];
- Estimated glomerular filtration rate (eGFR) < 60 mL/min (see Appendix 14.2 of the Clinical Study Protocol [V1.2/15Dec2020] for the formula) or urinary protein qualitative assessment ≥++;
- Subjects with alanine aminotransferase (ALT) or/and aspartate aminotransferase (AST) > 2.5 × ULN (upper limit of normal), or total bilirubin level > 1.5 × ULN;
- Subjects currently presenting with uncontrolled thyroid dysfunction despite a stable medication dosage (defined as a stable dose for 4 weeks or more) or clinically significant abnormalities in thyroid function test results (thyroid-stimulating hormone [TSH], serum free thyroxine [FT4], and free triiodothyronine [FT3]) at the time of screening;
- Subjects currently suffering from anaemia (haemoglobin <120 g/L for men and <110 g/L for women) or other conditions that affected HbA1c testing;
- Subjects with fasting triglyceride < 5.64 mmol/L (<500 mg/dL);
- Serum amylase or lipase >3×ULN;
- Subjects who were positive for Hepatitis B surface antigen, Hepatitis C antibody and human immunodeficiency virus (HIV) antibody (weakly positive was considered positive); Gender and reproductive status
- Subjects with positive pregnancy test;
- Subjects who were pregnant or lactating at enrollment;
- Female subjects of childbearing potential or male subjects with sexual partners of childbearing potential, who were unwilling to take medically recognized effective contraceptive measures (including condoms with spermicide, vaginal diaphragm, oral or injectable contraceptives) during the study and within 3 months after discontinuation; Other criteria
- Alcoholics [>2 units of alcohol per day and >14 units per week (1 unit of alcohol is equivalent to 150 mL of wine, 350 mL of beer, or 50 mL of spirits)] or individuals with a history of drug abuse;
- Subjects with blood donation or transfusion ≥ 400 mL within 3 months before screening;
- Subjects with mental deficiency or serious mental illness which might affect the signing of informed consent form and the compliance with the study protocol;
- Subjects who refused to take anti-diabetic drugs only specified in the protocol throughout the study;
- Hypersensitivity to Albenatide, human albumin (API for Albenatide formulations), Amaryl® (glimepiride tablets) or related excipients;
- Intolerance to Albenatide or Amaryl® (glimepiride tablets);
- Other conditions that are deemed inappropriate by the investigator to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of CJC-1134-PC Injection Administered Once Weekly in Antidiabetic Treatment-naive Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
This study is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of CJC-1134-PC Injection Administered Once Weekly in Antidiabetic Treatment-naive Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
- Conditions
- Type 2 Diabetes Mellitus - Poor Control
- Being tested
- CJC-1134-PC Injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJC-1134-PC InjectionDrug
Double-blind Treatment Period: 0.2ml (2mg) once weekly ×24 weeks (Week 1 to Week 24); Open-label Treatment Period: 0.2ml (2mg) once weekly ×28 weeks (Week 25 to Week 52)
PlaceboDrug
Double-blind Treatment Period: 0.2ml (0mg) once weekly ×24 weeks (Week 1 to Week 24); Open-label Treatment Period: 0.2ml (2mg) once weekly ×28 weeks (Week 25 to Week 52)
| Study group | Role | What they receive |
|---|---|---|
| CJC-1134-PC | Experimental | Injection, 0.2ml/2mg (prefilled pen) Receives: Drug: CJC-1134-PC Injection |
| Placebo | Placebo comparator | Injection, 0.2ml/0mg (prefilled pen) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c at the end of double-blind treatment period.
The double-blind treatment period ended at the 25-week visit.
Measured: Week 25 visit
Secondary outcomes (19)
Proportion of subjects with HbA1c <7.0% at the end of the double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Proportion of subjects with HbA1c <6.5% at the end of the double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting weight at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting waist circumference at the end of double-blind /open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting plasma glucose at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting proinsulin at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting insulin at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting C-peptide at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (total cholesterol) at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (low-density lipoprotein [LDL]) at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (high-density lipoprotein [HDL]) at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (triglycerides) at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (LDL/HDL ratio) at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in systolic blood pressure [SBP] at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in diastolic blood pressure [DBP] at the end of double-blind treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in 6-point finger-stick blood glucose at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in blood AST at the end of double-blind/open-label treatment period in patients diagnosed with fatty liver on screening imaging.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in blood ALT at the end of double-blind/open-label treatment period in patients diagnosed with fatty liver on screening imaging
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Change from baseline in HbA1c at the end of open-label treatment period.
The open-label treatment period ended at the 53-week visit.
Measured: Week 53 visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start16 Apr 2021
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus - Poor ControlStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changshan ConjuChem BioPharmaceutical Research and Development (Hebei) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linong Ji, Prof., Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058545
- Sponsor's protocol ID
- CSCJC DM302
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of CJC-1134-PC Injection Administered Once Weekly in Antidiabetic Treatment-naive Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
- ClinicalTrials.gov ID
- NCT07058545
- Acronym / sponsor ID
- CSCJC DM302
- Conditions
- Type 2 Diabetes Mellitus - Poor Control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Changshan ConjuChem BioPharmaceutical Research and Development (Hebei) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 10 Jul 2025 (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.
This study is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of CJC-1134-PC Injection Administered Once Weekly in Antidiabetic Treatment-naive Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CJC-1134-PC | Experimental | Drug: CJC-1134-PC InjectionInjection, 0.2ml/2mg (prefilled pen) |
| Placebo | Placebo comparator | Drug: PlaceboInjection, 0.2ml/0mg (prefilled pen) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects were eligible for the study only if all the following inclusion criteria were met:
- Males or females aged 18 - 70 years (inclusive) at screening;
- Subjects with body mass index (BMI) ≥ 20 kg/ m2 and ≤ 40 kg/ m2.
- Subjects diagnosed with type 2 diabetes mellitus according to 1999 World Health Organization (WHO) criteria;
- Subjects who had not received anti-diabetic therapy (including oral and injectable drugs, Chinese herbs for hypoglycemic purposes, and investigational anti-diabetic products, etc.) within 3 months prior to screening and had used anti-diabetic drugs for no more than 2 weeks since diagnosis;
Key exclusion criteria (37 listed)
- Prior and concomitant diseases
- Diagnosed as type 1 diabetes mellitus, diabetes mellitus due to pancreatic injury, or secondary diabetes mellitus caused by other diseases (e.g., acromegaly or Cushing syndrome);
- History of acute and chronic pancreatitis prior to screening or current history of acute and chronic pancreatitis;
- Presence of active gallbladder or biliary tract disease within 1 year prior to screening (active means presence of relevant symptoms);
- Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (family refers to first-degree blood relatives);
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 |
|---|---|---|
| CJC-1134-PC InjectionDouble-blind Treatment Period: 0.2ml (2mg) once weekly ×24 weeks (Week 1 to Week 24); Open-label Treatment Period: 0.2ml (2mg) once weekly ×28 weeks (Week 25 to Week 52) | Drug | CJC-1134-PC |
| PlaceboDouble-blind Treatment Period: 0.2ml (0mg) once weekly ×24 weeks (Week 1 to Week 24); Open-label Treatment Period: 0.2ml (2mg) once weekly ×28 weeks (Week 25 to Week 52) | Drug | Placebo |
Primary outcome
Change from baseline in HbA1c at the end of double-blind treatment period.
Time frame: Week 25 visit
The double-blind treatment period ended at the 25-week visit.
19 secondary outcomes
Proportion of subjects with HbA1c <7.0% at the end of the double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Proportion of subjects with HbA1c <6.5% at the end of the double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting weight at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting waist circumference at the end of double-blind /open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting plasma glucose at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting proinsulin at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting insulin at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting C-peptide at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (total cholesterol) at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (low-density lipoprotein [LDL]) at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (high-density lipoprotein [HDL]) at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (triglycerides) at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (LDL/HDL ratio) at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in systolic blood pressure [SBP] at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in diastolic blood pressure [DBP] at the end of double-blind treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in 6-point finger-stick blood glucose at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in blood AST at the end of double-blind/open-label treatment period in patients diagnosed with fatty liver on screening imaging.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in blood ALT at the end of double-blind/open-label treatment period in patients diagnosed with fatty liver on screening imaging
Time frame: Week 25 visit, and week 53 visit.
Change from baseline in HbA1c at the end of open-label treatment period.
Time frame: Week 53 visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Linong Ji, Prof. study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CJC-1134-PC Injection in people with Type 2 Diabetes Mellitus - Poor Control, run by Changshan ConjuChem BioPharmaceutical Research and Development (Hebei) 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 9 inclusion and 37 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 10 Jul 2025. 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?
Change from baseline in HbA1c at the end of double-blind treatment period. (time frame: Week 25 visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2025.