Type 2 Diabetic PatientsNCT03987308
Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly Diagnosed T2DM Patients
A study testing Beinaglutide and Insulin aspart in people with Type 2 Diabetic Patients and T2DM (Type 2 Diabetes Mellitus), run by Beijing Hospital at 16 sites in China.
Trial summary
The efficacy, safety and post-treatment disease control will be compared between groups of continuous subcutaneous Beinaglutide infusion and continuous subcutaneous insulin infusion (CSII) in adult patients with newly diagnosed type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetic Patients, T2DM (Type 2 Diabetes Mellitus), T2DM
- What is being tested?
- Beinaglutide and Insulin aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 16 sitesChina
- Study dates
- 2 Jul 2019to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 to 70 years (inclusive) at enrollment, regardless of gender.
- Voluntary signing of the informed consent form.
- Newly diagnosed type 2 diabetes mellitus patients, diagnosed according to the WHO 1999 criteria, with a disease duration ≤1 year.
- HbA1c between 7.5% and 10.0%.
- BMI between 24 kg/m² and 42 kg/m².
- Subjects who have not taken antidiabetic medications or have used oral antidiabetic medications for less than 3 months and have discontinued for more than 1 month (calculated from the date of signing the informed consent form).
- Subjects with reproductive potential (including male subjects whose partners have reproductive potential) agree to use effective contraception during the study and for 1 month after study completion.
Who cannot join
- Patients with type 1 diabetes or other types of diabetes.
- History of obstructive intestinal diseases or potential complications: subjects with post-abdominal surgery or peritoneal infection-related intestinal adhesions, intestinal obstruction sequelae; subjects with intestinal motility disorders, chronic constipation; subjects with a history of Crohn's disease or ulcerative colitis.
- History of pancreatitis.
- Family history of medullary thyroid carcinoma.
- History of malignant tumors.
- ALT, AST >3 times the upper limit of normal, and/or total bilirubin >2 times the upper limit of normal.
Show all 20Show fewer
- Moderate to severe renal insufficiency (eGFR <60 ml/min/1.73m²).
- Triglycerides ≥5.0 mmol/L.
- Multiple endocrine neoplasia type 2 (MEN 2).
- Participation in any pre-marketing drug study within 3 months.
- Use or expected use of systemic corticosteroids, immunosuppressants, or cytotoxic drugs during the study period.
- History of diabetic ketoacidosis or non-ketotic hyperosmolar coma within 6 months prior to screening.
- Blood pressure exceeding the following criteria (untreated or treated): systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg.
- History of any of the following cardiovascular diseases within 3 months prior to screening: acute myocardial infarction, New York Heart Association functional class III/IV heart failure or left ventricular ejection fraction ≤40%, or cerebrovascular event (stroke).
- Allergy to binaclotide or any component of the study drug, or allergy to insulin or any component of the insulin used in the study.
- Presence of other severe diseases that may interfere with the study, as judged by the investigator.
- Pregnant or breastfeeding women.
- Poor compliance, as judged by the investigator, and inability to complete the study as required.
- Inability to undergo continuous pump infusion: subjects allergic to subcutaneous infusion tubes or adhesive tape; subjects unwilling to have long-term subcutaneous infusion tubes or continuous pump use; subjects with psychological aversion to pump therapy; subjects or their families lack relevant knowledge and are unable to master the use after training; subjects with severe psychological disorders or mental abnormalities; subjects who are unable to care for themselves and have no caregivers.
- Any other factors deemed unsuitable for participation in the study by the investigator.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
Pinggu District Hospital
Beijing, Beijing Municipality, 000
Yufeng Li, M.D., +8613911080328, doctorlyf@126.com
- Recruiting
Capital Medical University Beijing Anzhen Hospital
Beijing, Beijing Municipality
Liping Ma, M.D., +8613901249835, maliping65@126.com
- Recruiting
Emergency General Hospital
Beijing, Beijing Municipality
Kailiang Wang, M.D., +8613911151692, maliping65@126.com
- Recruiting
Peking University Shougang Hospital
Beijing, Beijing Municipality
Xiuqin Sun, M.D., +8613552300467, sxqlyfxly@163.com
- Recruiting
First Hospital of Peking University
Beijing, 100034
Geheng Yuan, Ph.D. M.D., 13811235488, 139197109@qq.com
- Recruiting
China-Japan Union Hospital of Jilin University
Changchun, Jilin
Qing Wang, M.D., +8613614301117, wang_qing@jlu.edu.cn
- Recruiting
Jilin University Second Hospital
Changchun, Jilin
Hanqing Cai, M.D., +8613674315050, Caihanqing16@163.com
- Recruiting
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 000
Yaoming Xue, M.D., +8613926066999, yaomingxue@126.com
- Recruiting
Harbin Medical University Second Hospital
Harbin, Heilongjiang
Qiao Hong, M.D., +8613359854888, qiaoh0823@sina.com
- Recruiting
Heilongjiang provincial hospital
Harbin, 150030
Binhong Duan, M.D, Ph.D.
- Recruiting
Southwest Medical University Affiliated Hospital
Luzhou, Sichuan, 000
Xu Yong, M.D., +8613980255895, xywyll@aliyun.com
- Recruiting
Southeast University Zhongda Hospital
Nanjing, Jiangsu, 000
Ling Li, M.D., +8613951606816, endocrine2023@163.com
- Recruiting
Peking University Binhai Hospital
Tianjin, Tianjin Municipality
Su Wang, M.D., +8615122328988, wsrealm@163.com
- Recruiting
Xi'an Jiaotong University Second Hospital
Xi'an, Shaanxi, 000
Jing Xu, M.D., +8613772151682, xujingjdey85@163.com
- Recruiting
Xuzhou Medical University Affiliated Hospital
Xuzhou, Jiangsu
Hongwei Ling, M.D., +8618052268607, ling_hongwei@126.com
- Recruiting
Henan People's Hospital
Zhengzhou, 450003
Huijuan Yuan, Ph.D. M.D.
About this study
Official title: Comparing the Efficacy and Safety Between Short-term Continuous Subcutaneous Beinaglutide Injection and Continuous Subcutaneous Insulin Infusion (CSII) for Treatment of Patients With Newly Diagnosed Type 2 Diabetes: a Multicenter, Randomized Open Trial Study With Parallel Controls
The efficacy, safety and post-treatment disease control will be compared between groups of continuous subcutaneous Beinaglutide infusion and continuous subcutaneous insulin infusion (CSII) in adult patients with newly diagnosed type 2 diabetes.
Read the detailed description
Based on the dual roles of glucagon-like peptide 1 (GLP-1) in regulating fasting blood glucose and postprandial blood glucose secretion, we adopted a combinational therapeutic model and will administer drug treatments during meals. Newly diagnosed type 2 diabetic patients will be administered continuous subcutaneous Beinaglutide injections using a pump device. The efficacy, safety and disease control after terminating the drug treatments will be compared to those of patients who receive CSII treatment.
This is a national-level, multicenter, randomized, open study with parallel controls. The study consists of two phases:
a 8-week treatment phase and a 12-week post-treatment follow-up period.
- Being tested
- Beinaglutide, Insulin aspart
- Keywords
- T2DM, beinaglutide, CSII, subcutaneous pump
- 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.
BeinaglutideDrug
Beinaglutide (continuous subcutaneous infusion)
Insulin aspartDrug
Insulin aspart (CSII)
| Study group | Role | What they receive |
|---|---|---|
| Continuous Beinaglutide infusion | Experimental | 8-week Beinaglutide (continuous subcutaneous infusion) treatment group Receives: Drug: Beinaglutide |
| Continuouns Insulin aspart infusion | Active comparator | 8-week insulin aspart (CSII) treatment group Receives: Drug: Insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects achieving HbA1c <7.0%, no weight increase (≤0 kg), and no hypoglycemia (blood glucose ≤3.9 mmol/L or severe hypoglycemia) after 8 weeks of treatment.
The primary endpoint of the trial is a composite endpoint of HbA1c <7.0%, no weight increase (≤0 kg), and no hypoglycemia (blood glucose ≤3.9 mmol/L or severe hypoglycemia) after 8 weeks of treatment..
Measured: From baseline to the end of treatment at 8 week
Secondary outcomes (29)
Proportion of subjects achieving HbA1c reduction <7% after 8 weeks of treatment.
Proportion of participants achieving a reduction in HbA1c levels to below 7% after 8 weeks of treatment.
Measured: From baseline to the end of treatment at 8 week
Changes in fasting blood glucose from baseline after 8 weeks of treatment.
Changes in fasting blood glucose from baseline after 8 weeks of treatment.
Measured: From baseline to the end of treatment at 8 week
Changes in postprandial blood glucose from baseline after 8 weeks of treatment.
Changes in postprandial blood glucose from baseline after 8 weeks of treatment.
Measured: From baseline to the end of treatment at 8 week
Changes in HbA1C from baseline after 8 weeks of treatment.
Changes in HbA1C from baseline after 8 weeks of treatment.
Measured: From baseline to the end of treatment at 8 week
Proportion of subjects with weight reduction ≥5% from baseline after 8 weeks of treatment.
Proportion of subjects with weight reduction ≥5% from baseline after 8 weeks of treatment.
Measured: From baseline to the end of treatment at 8 week
Changes in weight from baseline after 8 weeks of treatment.
Changes in weight from baseline after 8 weeks of treatment.
Measured: From baseline to the end of treatment at 8 week
Changes in waist circumference from baseline after 8 weeks of treatment.
Changes in waist circumference from baseline after 8 weeks of treatment.
Measured: From baseline to the end of treatment at 8 week
Changes in waist-to-hip ratio from baseline after 8 weeks of treatment.
Changes in waist-to-hip ratio from baseline after 8 weeks of treatment.
Measured: From baseline to the end of treatment at 8 week
Changes in fasting insulin from baseline after 8 weeks of treatment.
Changes in fasting insulin from baseline after 8 weeks of treatment.
Measured: From baseline to the end of treatment at 8 week
Changes in fasting C-peptide from baseline after 8 weeks of treatment.
Changes in fasting C-peptide from baseline after 8 weeks of treatment.
Measured: From baseline to the end of treatment at 8 week
Changes in HOMA-β from baseline after 8 weeks of treatment.
Changes in HOMA-β from baseline after 8 weeks of treatment.
Measured: From baseline to the end of treatment at 8 week
Changes in HOMA-IR from baseline after 8 weeks of treatment.
Changes in HOMA-IR from baseline after 8 weeks of treatment.
Measured: From baseline to the end of treatment at 8 week
Changes in lipid profile from baseline after 8 weeks of treatment.
Changes in lipid profile from baseline after 8 weeks of treatment.
Measured: From baseline to the end of treatment at 8 week
Changes in blood pressure baseline after 8 weeks of treatment.
Changes in blood pressure (assessing both of systolic and diastolic pressure) from baseline after 8 weeks of treatment.
Measured: From baseline to the end of treatment at 8 week
Changes in heart rate from baseline after 8 weeks of treatment.
Changes in heart rate from baseline after 8 weeks of treatment.
Measured: From baseline to the end of treatment at 8 week
Proportion of subjects achieving HbA1c <6.5% at 20 weeks.
Proportion of subjects achieving HbA1c <6.5% at 20 weeks.
Measured: From baseline to week 20
Proportion of subjects achieving HbA1c <7% at 20 weeks.
Proportion of subjects achieving HbA1c <7% at 20 weeks.
Measured: From baseline to week 20
Proportion of subjects with fasting blood glucose <7.0 mmol/L at 20 weeks.
Proportion of subjects with fasting blood glucose <7.0 mmol/L at 20 weeks.
Measured: From baseline to week 20
Changes in weight from baseline at 20 weeks.
Changes in weight from baseline at 20 weeks.
Measured: From baseline to week 20
Changes in BMI from baseline at 20 weeks.
Changes in BMI from baseline at 20 weeks.
Measured: From baseline to week 20
Changes in waist-to-hip ratio from baseline at 20 weeks.
Changes in waist-to-hip ratio from baseline at 20 weeks.
Measured: From baseline to week 20
Changes in fasting blood glucose from baseline at 20 weeks.
Changes in fasting blood glucose HbA1c from baseline at 20 weeks.
Measured: From baseline to week 20
Changes in postprandial blood glucose from baseline at 20 weeks.
Changes in postprandial blood glucose from baseline at 20 weeks.
Measured: From baseline to week 20
Changes in HbA1c from baseline at 20 weeks.
Changes in HbA1c from baseline at 20 weeks.
Measured: From baseline to week 20
Changes in HOMA-β from baseline at 20 weeks.
Changes in HOMA-β from baseline at 20 weeks.
Measured: From baseline to week 20
Changes in HOMA-IR from baseline at 20 weeks.
Changes in HOMA-IR from baseline at 20 weeks.
Measured: From baseline to week 20
Changes in fasting insulin from baseline at 20 weeks.
Changes in fasting insulin from baseline at 20 weeks.
Measured: From baseline to week 20
Changes in fasting C-peptide from baseline at 20 weeks.
Changes in fasting C-peptide from baseline at 20 weeks.
Measured: From baseline to week 20
Changes in lipid profile from baseline at 20 weeks.
Changes in lipid profile from baseline at 20 weeks.
Measured: From baseline to week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start2 Jul 2019
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetic 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
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987308
- Sponsor's protocol ID
- BN-IIT-IS-008
- Status last verified
- Apr 2025
- First submitted
- 12 Jun 2019
- Last updated
- 2 May 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 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy and Safety Between Short-term Continuous Subcutaneous Beinaglutide Injection and Continuous Subcutaneous Insulin Infusion (CSII) for Treatment of Patients With Newly Diagnosed Type 2 Diabetes: a Multicenter, Randomized Open Trial Study With Parallel Controls
- ClinicalTrials.gov ID
- NCT03987308
- Acronym / sponsor ID
- BN-IIT-IS-008
- Keywords
- T2DM, beinaglutide, CSII, subcutaneous pump
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Jun 2019 (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.
The efficacy, safety and post-treatment disease control will be compared between groups of continuous subcutaneous Beinaglutide infusion and continuous subcutaneous insulin infusion (CSII) in adult patients with newly diagnosed type 2 diabetes.
Detailed description
Based on the dual roles of glucagon-like peptide 1 (GLP-1) in regulating fasting blood glucose and postprandial blood glucose secretion, we adopted a combinational therapeutic model and will administer drug treatments during meals. Newly diagnosed type 2 diabetic patients will be administered continuous subcutaneous Beinaglutide injections using a pump device. The efficacy, safety and disease control after terminating the drug treatments will be compared to those of patients who receive CSII treatment.
This is a national-level, multicenter, randomized, open study with parallel controls. The study consists of two phases:
a 8-week treatment phase and a 12-week post-treatment follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Beinaglutide infusion | Experimental | Drug: Beinaglutide8-week Beinaglutide (continuous subcutaneous infusion) treatment group |
| Continuouns Insulin aspart infusion | Active comparator | Drug: Insulin aspart8-week insulin aspart (CSII) treatment group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 70 years (inclusive) at enrollment, regardless of gender.
- Voluntary signing of the informed consent form.
- Newly diagnosed type 2 diabetes mellitus patients, diagnosed according to the WHO 1999 criteria, with a disease duration ≤1 year.
- HbA1c between 7.5% and 10.0%.
- BMI between 24 kg/m² and 42 kg/m².
Key exclusion criteria (20 listed)
- Patients with type 1 diabetes or other types of diabetes.
- History of obstructive intestinal diseases or potential complications: subjects with post-abdominal surgery or peritoneal infection-related intestinal adhesions, intestinal obstruction sequelae; subjects with intestinal motility disorders, chronic constipation; subjects with a history of Crohn's disease or ulcerative colitis.
- History of pancreatitis.
- Family history of medullary thyroid carcinoma.
- History of malignant tumors.
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 |
|---|---|---|
| BeinaglutideBeinaglutide (continuous subcutaneous infusion) | Drug | Continuous Beinaglutide infusion |
| Insulin aspartInsulin aspart (CSII) | Drug | Continuouns Insulin aspart infusion |
Primary outcome
The proportion of subjects achieving HbA1c <7.0%, no weight increase (≤0 kg), and no hypoglycemia (blood glucose ≤3.9 mmol/L or severe hypoglycemia) after 8 weeks of treatment.
Time frame: From baseline to the end of treatment at 8 week
The primary endpoint of the trial is a composite endpoint of HbA1c <7.0%, no weight increase (≤0 kg), and no hypoglycemia (blood glucose ≤3.9 mmol/L or severe hypoglycemia) after 8 weeks of treatment..
29 secondary outcomes
Proportion of subjects achieving HbA1c reduction <7% after 8 weeks of treatment.
Time frame: From baseline to the end of treatment at 8 week
Changes in fasting blood glucose from baseline after 8 weeks of treatment.
Time frame: From baseline to the end of treatment at 8 week
Changes in postprandial blood glucose from baseline after 8 weeks of treatment.
Time frame: From baseline to the end of treatment at 8 week
Changes in HbA1C from baseline after 8 weeks of treatment.
Time frame: From baseline to the end of treatment at 8 week
Proportion of subjects with weight reduction ≥5% from baseline after 8 weeks of treatment.
Time frame: From baseline to the end of treatment at 8 week
Changes in weight from baseline after 8 weeks of treatment.
Time frame: From baseline to the end of treatment at 8 week
Changes in waist circumference from baseline after 8 weeks of treatment.
Time frame: From baseline to the end of treatment at 8 week
Changes in waist-to-hip ratio from baseline after 8 weeks of treatment.
Time frame: From baseline to the end of treatment at 8 week
Changes in fasting insulin from baseline after 8 weeks of treatment.
Time frame: From baseline to the end of treatment at 8 week
Changes in fasting C-peptide from baseline after 8 weeks of treatment.
Time frame: From baseline to the end of treatment at 8 week
Changes in HOMA-β from baseline after 8 weeks of treatment.
Time frame: From baseline to the end of treatment at 8 week
Changes in HOMA-IR from baseline after 8 weeks of treatment.
Time frame: From baseline to the end of treatment at 8 week
Changes in lipid profile from baseline after 8 weeks of treatment.
Time frame: From baseline to the end of treatment at 8 week
Changes in blood pressure baseline after 8 weeks of treatment.
Time frame: From baseline to the end of treatment at 8 week
Changes in heart rate from baseline after 8 weeks of treatment.
Time frame: From baseline to the end of treatment at 8 week
Proportion of subjects achieving HbA1c <6.5% at 20 weeks.
Time frame: From baseline to week 20
Proportion of subjects achieving HbA1c <7% at 20 weeks.
Time frame: From baseline to week 20
Proportion of subjects with fasting blood glucose <7.0 mmol/L at 20 weeks.
Time frame: From baseline to week 20
Changes in weight from baseline at 20 weeks.
Time frame: From baseline to week 20
Changes in BMI from baseline at 20 weeks.
Time frame: From baseline to week 20
Changes in waist-to-hip ratio from baseline at 20 weeks.
Time frame: From baseline to week 20
Changes in fasting blood glucose from baseline at 20 weeks.
Time frame: From baseline to week 20
Changes in postprandial blood glucose from baseline at 20 weeks.
Time frame: From baseline to week 20
Changes in HbA1c from baseline at 20 weeks.
Time frame: From baseline to week 20
Changes in HOMA-β from baseline at 20 weeks.
Time frame: From baseline to week 20
Changes in HOMA-IR from baseline at 20 weeks.
Time frame: From baseline to week 20
Changes in fasting insulin from baseline at 20 weeks.
Time frame: From baseline to week 20
Changes in fasting C-peptide from baseline at 20 weeks.
Time frame: From baseline to week 20
Changes in lipid profile from baseline at 20 weeks.
Time frame: From baseline to week 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beinaglutide and Insulin aspart in people with Type 2 Diabetic Patients and T2DM (Type 2 Diabetes Mellitus), run by Beijing Hospital at 16 sites 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 20 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: looking for participants now, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lixin Guo, M.D.，Ph.D. (+8613901317569, glx1218@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects achieving HbA1c <7.0%, no weight increase (≤0 kg), and no hypoglycemia (blood glucose ≤3.9 mmol/L or severe hypoglycemia) after 8 weeks of treatment. (time frame: From baseline to the end of treatment at 8 week). 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 2 May 2025.