Type 2 DiabetesPhase 4NCT07307235
Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents
A Phase 4 study testing iGlarLixi (insulin glargine/lixisenatide) in people with Type 2 Diabetes, run by Shanghai Zhongshan Hospital at 24 sites in China.
Trial summary
This study is a prospective, open-label, multicenter, parallel-group, positive-controlled, and pragmatic randomized clinical trial (pRCT). It will compare the efficacy and safety of iGlarLixi versus standard of care in adult T2DM patients with poor glycemic control, who are using 1 to 3 OADs in a real-world clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- iGlarLixi (insulin glargine/lixisenatide)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,316 participants
- Where
- 24 sitesChina
- Study dates
- 13 Dec 2025to 30 Dec 2027
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be at least 18 of age inclusive, at the time of signing the informed consent.
- Type 2 diabetes mellitus diagnosis.
- Participants who are treated for at least 3 months prior to the screening visit with an adequate dose of 1-3 OADs.
- HbA1c 7.5-11%
- Further intensification with an additional antidiabetic injectable medication is indicated to achieve glycaemic target at the discretion of the study physician according to approval labelling.
- Participants who have signed informed consent form (ICF).
Who cannot join
- Diagnosed with T1DM
- BMI <20 kg/m2 or BMI ≥40 kg/m2
- Treatment with more than 3 oral antidiabetic medications, or any injectable medication in a period of 30 days before the day of eligibility assessment. Temporary/emergency use of insulin is allowed, as is prior insulin treatment for gestational diabetes.
- Contraindications to iGlarLixi according to the China NMPA approved label.
- Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study.
- Participants who involved in other clinical trial within 3 months prior to the time of screening visit.
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- Participant who has a severe renal function impairment with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
- Pregnant or breast-feeding woman.
- Woman of childbearing potential not protected by highly effective contraceptive method of birth control and/or who is unwilling or unable to be tested for pregnancy.
- Conditions/situations such as:
- Participant with short life expectancy. Participant with conditions/concomitant diseases making him/her not evaluable for the primary efficacy endpoint (eg, hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to screening).
- Participant with conditions/concomitant diseases precluding his/her safe participation in this study (eg, active malignant tumor, major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require laser treatment within the study period).
- Uncooperative or any condition that could make the participant potentially non-compliant to the study procedures.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
China24 sites, 24 recruiting
- Recruiting
The First Clinical Hospital of Jilin Academy of Chinese Medicine Sciences
Changchun, Jilin, 130021
Dan Lu, +86 431 86766888, 1204112563@qq.com
- Recruiting
Hunan Provincial People's Hospital / The First Affiliated Hospital of Hunan Normal University
Changsha, Hunan, 410005
Chi Zhang, +86 731 83929035, zhangcynthia@163.com
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Xiaohong Wu, +86 571 87666666, drxhwu@163.com
- Recruiting
Heilongjiang Provincial Hospital
Harbin, Heilongjiang, 150036
Fuman Du, +86 451 88025555, 13603603066@163.com
- Recruiting
The First Affiliated Hospital of USTC / Anhui Provincial Hospital
Hefei, Anhui, 230001
Wei Wang, +86 551 62283114, hfww2001@163.com
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Qiu Zhang, +86 551 62922800, aynfmk@163.com
- Recruiting
Hengyang Central Hospital
Hengyang, Hunan, 421001
Hanmei Duan, +86 734 8275708, 15477164@qq.com
- Recruiting
Affiliated Nanhua Hospital, University of South China
Hengyang, Hunan, 421002
Guojuan Li, +86 734 8358018, 524008651@qq.com
- Recruiting
The First People's Hospital of Huizhou
Huizhou, Guangdong, 516003
Liqiang Chen, +86 752 2883800, Chenlq1137@163.com
- Recruiting
Jiaxing First Hospital
Jiaxing, Zhejiang, 314001
Qiang Zhou, +86 573 82519999, zhouqiang8004@163.com
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Jianping Liu, +86 791 86120120, liujpnfm@163.com
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210003
Yibing Lu, +86 25 58509900, luyibing2004@126.com
- Recruiting
Ningbo No. 2 Hospital
Ningbo, Zhejiang, 315010
Mingchen Zhang, +86 574 83870999, Zhangmc1015@163.com
- Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315040
Lingling Fang, +86 574 87018701, cxyangy@126.com
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Xiaoying Li, +86 21 64041990, li.xiaoying@zs-hospital.sh.cn
- Recruiting
Shanghai Tenth People's Hospital / Tenth People's Hospital of Tongji University
Shanghai, Shanghai Municipality, 200072
Haibing Chen, +86 21 66300588, 18930173813@163.com
- Recruiting
Shanghai East Hospital, Tongji University
Shanghai, Shanghai Municipality, 200120
Bo Feng, +86 21 38804518, fengbodyff@tongji.edu.cn
- Recruiting
Shanghai Pudong New Area Punan Hospital
Shanghai, Shanghai Municipality, 200125
Lianyong Liu, +86 21 20302000, Chinallu@163.com
- Recruiting
Shanghai Tongren Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200336
Shan Huang, +86 21 52039999
- Recruiting
Minhang Hospital, Fudan University / Central Hospital of Minhang District, Shanghai
Shanghai, Shanghai Municipality, 201199
Yuping Song, +86 21 64923400, 15901838098@163.com
- Recruiting
Shanghai Qingpu District Central Hospital / Qingpu Branch of Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 201700
Min Zhang, +86 21 67009999, 18116016187@163.com
- Recruiting
Shenzhen Third People's Hospital
Shenzhen, Guangdong, 518112
Weihua Wu, +86 755 61222333, hui-90@163.com
- Recruiting
Wuhan Fourth Hospital / Wuhan Puai Hospital
Wuhan, Hubei, 430030
Mei Lin, +86 27 83782519, lmei2007@163.com
- Recruiting
Xinxiang Central Hospital
Xinxiang, Henan, 453003
Yanhong Zhou, +86 373 3530300, Zhouyanhong@163.com
About this study
Official title: Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents-a Pragmatic Randomized Controlled Trial
This study is a prospective, open-label, multicenter, parallel-group, positive-controlled, and pragmatic randomized clinical trial (pRCT). It will compare the efficacy and safety of iGlarLixi versus standard of care in adult T2DM patients with poor glycemic control, who are using 1 to 3 OADs in a real-world clinical practice setting. A total of 1,316 subjects from approximately 40 research centers in China will be randomly assigned in a 1:1 ratio to one of the following treatment groups: Group 1: iGlarLixi for blood glucose control; and Group 2: Standard of care for diabetes (basal insulin or premixed insulin, excluding any GLP-1RA-containing drugs). Considering the substantial difference in intervention methods between the two groups, the study is designed as non-blinded with an open-label approach.
- Conditions
- Type 2 Diabetes
- Being tested
- iGlarLixi (insulin glargine/lixisenatide), standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs)
- Keywords
- diabetes, iGlarLixi, RCT
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iGlarLixi (insulin glargine/lixisenatide)Drug
The investigational drug is iGlarLixi. Participants will receive subcutaneous injections of iGlarLixi with the OAD treatment regimen being appropriately maintained or adjusted as intensification therapy in routine clinical practice.
standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs)Drug
The control drug treatment is standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs). Participants will receive standard of care with the OAD treatment regimen being maintained or appropriately adjusted as an intensification treatment during routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| iGlarLixi group | Experimental | The investigational drug is iGlarLixi. Participants will receive subcutaneous injections of iGlarLixi with the OAD treatment regimen being appropriately maintained or adjusted as intensification therapy in routine clinical practice. Receives: Drug: iGlarLixi (insulin glargine/lixisenatide) |
| Standard of care (SOC) group. | Active comparator | The control drug treatment is standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs). Participants will receive standard of care with the OAD treatment regimen being maintained or appropriately adjusted as an intensification treatment during routine clinical practice. Receives: Drug: standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin A1c (HbA1c) change
The primary endpoint is the change in HbA1c from baseline to week 24 (percentage [%]).
Measured: from baseline to week 24
Secondary outcomes (23)
Proportion of subjects achieving HbA1c < 7% at week 24
Measured: 24 weeks
Proportion of subjects achieving HbA1c < 7%, with no weight gain and no hypoglycemia (defined as ADA grades 1, 2, or 3) at week 24
Measured: 24 weeks
Change in weight from baseline to week 24
Measured: 24 weeks
Change in Fasting plasma glucose from baseline to Week 24.
Measured: 24 weeks
Change in 7-point self-monitored plasma glucose (SMPG) profile from baseline to Week 24 (each time point and average daily value).
Measured: 24 weeks
Proportion of participants reaching HbA1c target <7% with no hypoglycemia (defined as ADA level 1, 2 or 3) at Week 24.
Measured: 24 weeks
Proportion of participants reaching HbA1c target <7% with no clinically relevant hypoglycemia (defined as ADA level 2 or 3) at Week 24
Measured: 24 weeks
Change in CGM metrics(TIR / TAR / TBR /mean daily glucose / TITR / CV / GMI / SD of mean glucose) from baseline to Week 24
Measured: 24 weeks
Change in proportion of patients achieving CGM metrics targets (TIR / TAR / TBR / TITR / CV) from baseline to Week 24
Measured: 24 weeks
Change in waist from baseline to Week 24
Measured: 24 weeks
Total insulin dose in each group at Week 24
Measured: 24 weeks
Change in fasting C-peptide from baseline to Week 24
Measured: 24 weeks
Percentage of participants requiring rescue therapy during the 24-week treatment period
Measured: 24 weeks
Time to first study drug discontinuation during 24 weeks (day)
Measured: 24 weeks
Time to first treatment intensification (add-on) or change (switch) after randomization during 24 weeks (day)
Measured: 24 weeks
Study drug medication adherence of the study, as measured by medication possession ratio (MPR) (%)
Measured: 24 weeks
Change from baseline to Week 24 in diabetes medication treatment satisfaction scores (total score and by sub scales), using the treatment related impact measure diabetes (TRIM-D) questionnaire.
TRIM scores range from 0 to 100 with a higher score indicating a better health state.
Measured: 24 weeks
All cause healthcare resource utilization (HCRU) from baseline to EOT（end of treatment
Measured: 24 weeks
Incidence and event rate of hypoglycemia
any hypoglycemia, ADA grades 1-2-3
Measured: 24 weeks
Incidence and event rate of Adverse events (AE)
Measured: 24 weeks
Incidence and event rate of serious adverse events (SAE)
An SAE is defined as any adverse event occurring at any dose that meets one or more of the following criteria:
- Results in death
- Is life-threatening
- Requires hospitalization or prolongs existing hospitalization
- Results in persistent or significant disability/incapacity
- Is a congenital anomaly/birth defect
- Other important medical events
Measured: 24 weeks
Incidence and event rate of adverse events of special interest (AESI)
The following events are designated as AESIs:
- Pregnancy in female subjects or pregnancy in female partners of male subjects exposed to IMP/NIMP
- Symptomatic overdose of IMP/NIMP (serious or non-serious)
- Alanine aminotransferase (ALT) elevation >3×ULN
Measured: 24 weeks
Incidence and event rate of AEs leading to treatment discontinuation, vital signs, and safety laboratory test values.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start13 Dec 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi (China) Investment Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307235
- Sponsor's protocol ID
- 20250424044409703
- Status last verified
- Jul 2026
- First submitted
- 28 Nov 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents-a Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07307235
- Acronym / sponsor ID
- 20250424044409703
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes, iGlarLixi, RCT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,316 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Sanofi (China) Investment Co., Ltd
- Study start
- 13 Dec 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Dec 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 prospective, open-label, multicenter, parallel-group, positive-controlled, and pragmatic randomized clinical trial (pRCT). It will compare the efficacy and safety of iGlarLixi versus standard of care in adult T2DM patients with poor glycemic control, who are using 1 to 3 OADs in a real-world clinical practice setting. A total of 1,316 subjects from approximately 40 research centers in China will be randomly assigned in a 1:1 ratio to one of the following treatment groups: Group 1: iGlarLixi for blood glucose control; and Group 2: Standard of care for diabetes (basal insulin or premixed insulin, excluding any GLP-1RA-containing drugs). Considering the substantial difference in intervention methods between the two groups, the study is designed as non-blinded with an open-label approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iGlarLixi group | Experimental | Drug: iGlarLixi (insulin glargine/lixisenatide)The investigational drug is iGlarLixi. Participants will receive subcutaneous injections of iGlarLixi with the OAD treatment regimen being appropriately maintained or adjusted as intensification therapy in routine clinical practice. |
| Standard of care (SOC) group. | Active comparator | Drug: standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs)The control drug treatment is standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs). Participants will receive standard of care with the OAD treatment regimen being maintained or appropriately adjusted as an intensification treatment during routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant must be at least 18 of age inclusive, at the time of signing the informed consent.
- Type 2 diabetes mellitus diagnosis.
- Participants who are treated for at least 3 months prior to the screening visit with an adequate dose of 1-3 OADs.
- HbA1c 7.5-11%
- Further intensification with an additional antidiabetic injectable medication is indicated to achieve glycaemic target at the discretion of the study physician according to approval labelling.
Key exclusion criteria (13 listed)
- Diagnosed with T1DM
- BMI <20 kg/m2 or BMI ≥40 kg/m2
- Treatment with more than 3 oral antidiabetic medications, or any injectable medication in a period of 30 days before the day of eligibility assessment. Temporary/emergency use of insulin is allowed, as is prior insulin treatment for gestational diabetes.
- Contraindications to iGlarLixi according to the China NMPA approved label.
- Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study.
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 |
|---|---|---|
| iGlarLixi (insulin glargine/lixisenatide)The investigational drug is iGlarLixi. Participants will receive subcutaneous injections of iGlarLixi with the OAD treatment regimen being appropriately maintained or adjusted as intensification therapy in routine clinical practice. | Drug | iGlarLixi group |
| standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs)The control drug treatment is standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs). Participants will receive standard of care with the OAD treatment regimen being maintained or appropriately adjusted as an intensification treatment during routine clinical practice. | Drug | Standard of care (SOC) group. |
Primary outcome
hemoglobin A1c (HbA1c) change
Time frame: from baseline to week 24
The primary endpoint is the change in HbA1c from baseline to week 24 (percentage [%]).
23 secondary outcomes
Proportion of subjects achieving HbA1c < 7% at week 24
Time frame: 24 weeks
Proportion of subjects achieving HbA1c < 7%, with no weight gain and no hypoglycemia (defined as ADA grades 1, 2, or 3) at week 24
Time frame: 24 weeks
Change in weight from baseline to week 24
Time frame: 24 weeks
Change in Fasting plasma glucose from baseline to Week 24.
Time frame: 24 weeks
Change in 7-point self-monitored plasma glucose (SMPG) profile from baseline to Week 24 (each time point and average daily value).
Time frame: 24 weeks
Proportion of participants reaching HbA1c target <7% with no hypoglycemia (defined as ADA level 1, 2 or 3) at Week 24.
Time frame: 24 weeks
Proportion of participants reaching HbA1c target <7% with no clinically relevant hypoglycemia (defined as ADA level 2 or 3) at Week 24
Time frame: 24 weeks
Change in CGM metrics(TIR / TAR / TBR /mean daily glucose / TITR / CV / GMI / SD of mean glucose) from baseline to Week 24
Time frame: 24 weeks
Change in proportion of patients achieving CGM metrics targets (TIR / TAR / TBR / TITR / CV) from baseline to Week 24
Time frame: 24 weeks
Change in waist from baseline to Week 24
Time frame: 24 weeks
Total insulin dose in each group at Week 24
Time frame: 24 weeks
Change in fasting C-peptide from baseline to Week 24
Time frame: 24 weeks
Percentage of participants requiring rescue therapy during the 24-week treatment period
Time frame: 24 weeks
Time to first study drug discontinuation during 24 weeks (day)
Time frame: 24 weeks
Time to first treatment intensification (add-on) or change (switch) after randomization during 24 weeks (day)
Time frame: 24 weeks
Study drug medication adherence of the study, as measured by medication possession ratio (MPR) (%)
Time frame: 24 weeks
Change from baseline to Week 24 in diabetes medication treatment satisfaction scores (total score and by sub scales), using the treatment related impact measure diabetes (TRIM-D) questionnaire.
Time frame: 24 weeks
All cause healthcare resource utilization (HCRU) from baseline to EOT（end of treatment
Time frame: 24 weeks
Incidence and event rate of hypoglycemia
Time frame: 24 weeks
Incidence and event rate of Adverse events (AE)
Time frame: 24 weeks
Incidence and event rate of serious adverse events (SAE)
Time frame: 24 weeks
Incidence and event rate of adverse events of special interest (AESI)
Time frame: 24 weeks
Incidence and event rate of AEs leading to treatment discontinuation, vital signs, and safety laboratory test values.
Time frame: 24 weeks
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 7 Jul 2026.
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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.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing iGlarLixi (insulin glargine/lixisenatide) in people with Type 2 Diabetes, run by Shanghai Zhongshan Hospital at 24 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 6 inclusion and 13 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiaoying li, Professor (+862164041990, li.xiaoying@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemoglobin A1c (HbA1c) change (time frame: from baseline to week 24). 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 7 Jul 2026.