Type 2 Diabetes Mellitus (T2DM)Phase 4NCT06327815
Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM
A Phase 4 study testing Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets and Dapagliflozin tablets and Metformin HCl extended-release tablets in people with Type 2 Diabetes Mellitus (T2DM), run by AstraZeneca at 35 sites in China.
Trial summary
Study D1690L00149 is a 24-week, multicentre, randomized, parallel, interventional, non-inferiority, open-label study designed to compare the FDC Regimen of Dapagliflozin/Metformin XR with the Dapagliflozin co-administered with Metformin XR in glycemic lowering control, satisfaction and adherence in Chinese patients… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets and Dapagliflozin tablets and Metformin HCl extended-release tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 633 participants
- Where
- 35 sitesChina
- Study dates
- 15 Mar 2024to 30 Jun 2025
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age and Informed Consent
- Patient must be 18 to 80 (years of age inclusive), at the time of signing the ICF(s).
- Type of Patient and Disease Characteristics
- Newly diagnosed T2DM (WHO diagnostic criteria 1999) ≤ 1 year with medicine treatment naïve.
- HbA1c 7.5%-10% at screening by local lab and HbA1c 7.5-10% at pre-randomization visit (by central laboratory).
- BMI ≥19 and ≤40 kg/m2 at screening. Other Inclusion Criteria
- Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Who cannot join
- Medical Conditions
- Congestive heart failure NYHA classes III or IV or major cardiovascular events within 6 months before screening. (Significant cardiovascular history within the past 6 months prior to screening defined as: myocardial infarction, coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident.)
- Patients with clinically apparent hepatobiliary disease, including but not limited to chronic active hepatitis and/or severe hepatic insufficiency. ALT or AST > 3x ULN, or serum TB >34.2 μmol/L (>2 mg/dL).
- Patients with eGFR< 45 mL/min per 1.73 m².
- Diagnosis or history of acute metabolic diabetic complications such as ketoacidosis or hyperglycemic hyperosmolar state, or diabetes insipidus within the past 6 months.
- For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
Show all 23Show fewer
- Participation in any other study that included drug treatment during the past 3 months before enrolment.
- Diagnostic Assessments
- Patients with a known hypersensitivity to Dapa/Met or any of the excipients of the product.
- Diagnosis or history of:
- Chronic pancreatitis within past 6 months or idiopathic acute pancreatitis within past 4 weeks.
- Gastrointestinal disease including gastroenterostomy, enterectomy, roemheld syndrome, severe hernia, intestinal obstruction, intestinal ulcer within past 6 months.
- Genetic galactose intolerance, lapp lactase deficiency and glucose-galactose malabsorption.
- Medullary thyroid carcinoma within past 5 years.
- Organ transplant or AIDS within the past 6 months.
- Alcohol abuse or illegal drug abuse within the past 12 months.
- Laser treatment for proliferative retinopathy within 6 months.
- Stress condition, such as surgery, serious trauma, etc., within past 6 months, or plan to undergo a surgery during study period.
- Chronic oxygen deficiency diseases, such as pulmonary emphysema, pulmonary heart disease within past 6 months.
- T1DM, diabetes resulting from pancreatic injury or secondary forms of diabetes, eg, acromegaly or Cushing's syndrome.
- Other Exclusions
- Subject is, in the judgment of the Investigator, unlikely to comply with the protocol or has any severe concurrent medical or psychological condition that may affect the interpretation of study results.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
China35 sites
Research Site
Beijing, 100020
Research Site
Beijing, 100050
Research Site
Beijing, 100076
Research Site
Beijing, 102218
Research Site
Changsha, 410005
Research Site
Chengdu, 610072
Research Site
Chongqing, 402260
Research Site
Chuxiong, 675000
Research Site
Dalian, 116001
Research Site
Dingzhou, 562100
Research Site
Fuyang, 236400
Research Site
Guangzhou, 510180
Research Site
Guangzhou, 510515
Research Site
Guiyang, 550044
Research Site
Hefei, 230012
Research Site
Jiangyin, 214400
Research Site
Jiyuan, 459003
Research Site
Kunming, 650032
Research Site
Nanchang, 330006
Research Site
Nanning
Research Site
Nantong, 226001
Research Site
Panjin, 124000
Research Site
Qingdao, 266200
Research Site
Quanzhou, 362000
Research Site
Rui’an, 325200
Research Site
Shenzhen, 518101
Research Site
Suzhou, 215500
Research Site
Taiyuan, 030001
Research Site
Tianjin, 300134
Research Site
Weifang, 261035
Research Site
Wenzhou, 325000
Research Site
Wuhan, 430010
Research Site
Yibin, 610500
Research Site
Zhengzhou, 450052
Research Site
Zhuji, 311899
About this study
Official title: Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM: A 24-Week, Multicentre, Randomized, Parallel, Interventional, Non-inferiority, Open-label Study
Study D1690L00149 is a 24-week, multicentre, randomized, parallel, interventional, non-inferiority, open-label study designed to compare the FDC Regimen of Dapagliflozin/Metformin XR with the Dapagliflozin co-administered with Metformin XR in glycemic lowering control, satisfaction and adherence in Chinese patients with T2DM.
Read the detailed description
The past 30 years have witnessed significant increases in the prevalence of type 2 diabetes mellitus (T2DM) in China. China now is estimated 114 million people with diabetes, T2DM accounts for more than 90% of the overall population with diabetes in China. A large proportion of diabetes is undiagnosed in China: in the 2007-2008 national survey among adult population over 20 years, patient with newly diagnosed diabetes accounted for 60% of total diabetes population. In the Healthy China 2030 Plan, approved by the State Council and the Party's Central Committee, diabetes, along with cancer, hypertension, and cardiovascular diseases, are listed as the four major non-communicable diseases (NCDs) for which the goal is to "control the prevalence and reduce the probability of early death". Metformin hydrochloride is the primary biguanide medication currently used in China's medical practice. Sodium-glucose cotransporter 2 (SGLT2) inhibitors used to be considered as second-line treatment after Metformin in patients with T2DM. But according to the American Diabetes Association (ADA) 2023 Standards of Medical Care in Diabetes, SGLT2 inhibitors are now recommended to be started at the time of diagnosis as the first-line medications, for high-risk individuals with atherosclerotic cardiovascular disease (ASCVD), heart failure (HF) or chronic kidney disease (CKD). Compared with stepwise therapy, early combination therapy may provide earlier and greater reductions in HbA1c and thus achievement of glycemic target. In addition, SGLT2 inhibitors provide cardiorenal protection both in patients with and without T2DM, that goes beyond glycemic control, hence the recommendation by guidelines to implement SGLT2 inhibitors. But early combination therapy is not fully implemented into clinical practice in China. International and CDS guidelines recommends encourage using fixed-dose combination (FDC) to have better adherence, which is associated with lower HbA1c, lower cost and less need for acute care. But in practice, FDC is not popular in China because of many reasons. One of the main arguments is that physicians think FDC lacks flexibility. Compelling evidence has shown that the co-administration of Dapagliflozin and Metformin extended-release (XR) tablets is superior to either of the monotherapy efficacy (Dapagliflozin or Metformin XR). Xigduo XR combines those two anti-hyperglycemic medicinal products with different and complementary mechanisms of action to improve glycemic control in patients with T2DM. Bioequivalence was demonstrated between FDC regimen and coadministered Dapagliflozin and Metformin HCl XR tablets. This dosage of Dapagliflozin 10 mg/Metformin hydrochloride XR 1000 mg FDC (Xigduo XR) has no clinical evidence except that bioequivalence study in China, and there are no combination therapy data available either for Chinese people. (Metformin XR usual dose is 1500-2000mg/d). Moreover, there is no head-to-head study comparing Dapa/Met FDC and co-administration therapies to the extra benefits of FDC.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets, Dapagliflozin tablets and Metformin HCl extended-release tablets
- 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.
Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tabletsDrug
Also called FDC Regimen of Dapagliflozin/Metformin XR
10 mg Dapagliflozin/1000 mg Metformin HCl extended-release
Dapagliflozin tablets and Metformin HCl extended-release tabletsDrug
Also called Co-administered Dual Therapy
Dapagliflozin tablets: 10 mg Metformin HCl extended-release tablets: 1000 mg
| Study group | Role | What they receive |
|---|---|---|
| Co-administered Dual Therapy | Active comparator | Dapagliflozin tablets and Metformin HCl extended-release tablets Receives: Drug: Dapagliflozin tablets and Metformin HCl extended-release tablets |
| FDC Regimen of Dapagliflozin/Metformin XR | Experimental | Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets Receives: Drug: Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline
To demonstrate non-inferiority of Dapa/Met FDC regimen when compared with Dapa + Met co-administered with respect to the primary efficacy endpoint.
Measured: 24 weeks
Secondary outcomes (6)
Proportion of patients achieved HbA1c less than 7.0% from baseline to week 24.
To describe the changes from baseline at Week 24 in proportion of patients with HbA1c < 7%.
Measured: 24 weeks
Absolute change in FPG from baseline to week 24.
To describe the changes from baseline at Week 24 in fasting plasma glucose (FPG).
Measured: 24 weeks
Absolute change in PPG from baseline to week 24.
To describe the changes from baseline at Week 24 in postprandial glucose (PPG).
Measured: 24 weeks
The difference in satisfaction scores between 2 groups measured with the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at week 24.
To evaluate the difference in satisfaction of FDC versus co-administered dual therapy in Chinese patients with T2DM. The minimum value is 0, the maximum value is 36, higher scores mean a better outcome.
Measured: Week 24
The difference in quality of life between 2 groups measured with Diabetes Quality of Life (DQOL) questionnaire at week 12 and week 24.
To evaluate the difference in quality of life of FDC versus co-administered dual therapy in Chinese patients with T2DM.
DQOL-Satisfaction: the minimum value is 15, the maximum value is 75, higher scores mean a worse outcome.
DQOL-Impact: the minimum value is 20, the maximum value is 100, higher scores mean a worse outcome.
DQOL-Worry: the minimum value is 11, the maximum value is 55, higher scores mean a worse outcome.
Measured: Week 12 and Week 24
To evaluate the difference in adherence of FDC versus co-administered dual therapy by Morisky Medication Adherence Scale-8 (MMAS-8) questionnaire in Chinese patients with T2DM.
To evaluate the difference in adherence of FDC versus co-administered dual therapy in Chinese patients with T2DM. The minimum value is 0, the maximum value is 8, higher scores mean a better outcome.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start15 Mar 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- 633 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guang Wang, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327815
- Sponsor's protocol ID
- D1690L00149
- Status last verified
- Oct 2025
- First submitted
- 19 Feb 2024
- Last updated
- 31 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Publications
Boye KS, Curtis SE, Lage MJ, Garcia-Perez LE. Associations between adherence and outcomes among older, type 2 diabetes patients: evidence from a Medicare Supplemental database. Patient Prefer Adherence. 2016 Aug 16;10:1573-81. doi: 10.2147/PPA.S107543. eCollection 2016.
PubMed 27574406Han S, Iglay K, Davies MJ, Zhang Q, Radican L. Glycemic effectiveness and medication adherence with fixed-dose combination or coadministered dual therapy of antihyperglycemic regimens: a meta-analysis. Curr Med Res Opin. 2012 Jun;28(6):969-77. doi: 10.1185/03007995.2012.684045. Epub 2012 May 3.
PubMed 22494018
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM: A 24-Week, Multicentre, Randomized, Parallel, Interventional, Non-inferiority, Open-label Study
- ClinicalTrials.gov ID
- NCT06327815
- Acronym / sponsor ID
- D1690L00149
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 633 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 25 Mar 2024 (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.
Study D1690L00149 is a 24-week, multicentre, randomized, parallel, interventional, non-inferiority, open-label study designed to compare the FDC Regimen of Dapagliflozin/Metformin XR with the Dapagliflozin co-administered with Metformin XR in glycemic lowering control, satisfaction and adherence in Chinese patients with T2DM.
Detailed description
The past 30 years have witnessed significant increases in the prevalence of type 2 diabetes mellitus (T2DM) in China. China now is estimated 114 million people with diabetes, T2DM accounts for more than 90% of the overall population with diabetes in China. A large proportion of diabetes is undiagnosed in China: in the 2007-2008 national survey among adult population over 20 years, patient with newly diagnosed diabetes accounted for 60% of total diabetes population. In the Healthy China 2030 Plan, approved by the State Council and the Party's Central Committee, diabetes, along with cancer, hypertension, and cardiovascular diseases, are listed as the four major non-communicable diseases (NCDs) for which the goal is to "control the prevalence and reduce the probability of early death". Metformin hydrochloride is the primary biguanide medication currently used in China's medical practice. Sodium-glucose cotransporter 2 (SGLT2) inhibitors used to be considered as second-line treatment after Metformin in patients with T2DM. But according to the American Diabetes Association (ADA) 2023 Standards of Medical Care in Diabetes, SGLT2 inhibitors are now recommended to be started at the time of diagnosis as the first-line medications, for high-risk individuals with atherosclerotic cardiovascular disease (ASCVD), heart failure (HF) or chronic kidney disease (CKD). Compared with stepwise therapy, early combination therapy may provide earlier and greater reductions in HbA1c and thus achievement of glycemic target. In addition, SGLT2 inhibitors provide cardiorenal protection both in patients with and without T2DM, that goes beyond glycemic control, hence the recommendation by guidelines to implement SGLT2 inhibitors. But early combination therapy is not fully implemented into clinical practice in China. International and CDS guidelines recommends encourage using fixed-dose combination (FDC) to have better adherence, which is associated with lower HbA1c, lower cost and less need for acute care. But in practice, FDC is not popular in China because of many reasons. One of the main arguments is that physicians think FDC lacks flexibility. Compelling evidence has shown that the co-administration of Dapagliflozin and Metformin extended-release (XR) tablets is superior to either of the monotherapy efficacy (Dapagliflozin or Metformin XR). Xigduo XR combines those two anti-hyperglycemic medicinal products with different and complementary mechanisms of action to improve glycemic control in patients with T2DM. Bioequivalence was demonstrated between FDC regimen and coadministered Dapagliflozin and Metformin HCl XR tablets. This dosage of Dapagliflozin 10 mg/Metformin hydrochloride XR 1000 mg FDC (Xigduo XR) has no clinical evidence except that bioequivalence study in China, and there are no combination therapy data available either for Chinese people. (Metformin XR usual dose is 1500-2000mg/d). Moreover, there is no head-to-head study comparing Dapa/Met FDC and co-administration therapies to the extra benefits of FDC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Co-administered Dual Therapy | Active comparator | Drug: Dapagliflozin tablets and Metformin HCl extended-release tabletsDapagliflozin tablets and Metformin HCl extended-release tablets |
| FDC Regimen of Dapagliflozin/Metformin XR | Experimental | Drug: Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tabletsXigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age and Informed Consent
- Patient must be 18 to 80 (years of age inclusive), at the time of signing the ICF(s).
- Type of Patient and Disease Characteristics
- Newly diagnosed T2DM (WHO diagnostic criteria 1999) ≤ 1 year with medicine treatment naïve.
- HbA1c 7.5%-10% at screening by local lab and HbA1c 7.5-10% at pre-randomization visit (by central laboratory).
Key exclusion criteria (23 listed)
- Medical Conditions
- Congestive heart failure NYHA classes III or IV or major cardiovascular events within 6 months before screening. (Significant cardiovascular history within the past 6 months prior to screening defined as: myocardial infarction, coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident.)
- Patients with clinically apparent hepatobiliary disease, including but not limited to chronic active hepatitis and/or severe hepatic insufficiency. ALT or AST > 3x ULN, or serum TB >34.2 μmol/L (>2 mg/dL).
- Patients with eGFR< 45 mL/min per 1.73 m².
- Diagnosis or history of acute metabolic diabetic complications such as ketoacidosis or hyperglycemic hyperosmolar state, or diabetes insipidus within the past 6 months.
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 |
|---|---|---|
| Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tabletsAlso: FDC Regimen of Dapagliflozin/Metformin XR10 mg Dapagliflozin/1000 mg Metformin HCl extended-release | Drug | FDC Regimen of Dapagliflozin/Metformin XR |
| Dapagliflozin tablets and Metformin HCl extended-release tabletsAlso: Co-administered Dual TherapyDapagliflozin tablets: 10 mg Metformin HCl extended-release tablets: 1000 mg | Drug | Co-administered Dual Therapy |
Primary outcome
Change in HbA1c from baseline
Time frame: 24 weeks
To demonstrate non-inferiority of Dapa/Met FDC regimen when compared with Dapa + Met co-administered with respect to the primary efficacy endpoint.
6 secondary outcomes
Proportion of patients achieved HbA1c less than 7.0% from baseline to week 24.
Time frame: 24 weeks
Absolute change in FPG from baseline to week 24.
Time frame: 24 weeks
Absolute change in PPG from baseline to week 24.
Time frame: 24 weeks
The difference in satisfaction scores between 2 groups measured with the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at week 24.
Time frame: Week 24
The difference in quality of life between 2 groups measured with Diabetes Quality of Life (DQOL) questionnaire at week 12 and week 24.
Time frame: Week 12 and Week 24
To evaluate the difference in adherence of FDC versus co-administered dual therapy by Morisky Medication Adherence Scale-8 (MMAS-8) questionnaire in Chinese patients with T2DM.
Time frame: Week 24
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 31 Oct 2025.
- Background: PubMed 27574406Boye KS, Curtis SE, Lage MJ, Garcia-Perez LE. Associations between adherence and outcomes among older, type 2 diabetes patients: evidence from a Medicare Supplemental database. Patient Prefer Adherence. 2016 Aug 16;10:1573-81. doi: 10.2147/PPA.S107543. eCollection 2016.
- Background: PubMed 22494018Han S, Iglay K, Davies MJ, Zhang Q, Radican L. Glycemic effectiveness and medication adherence with fixed-dose combination or coadministered dual therapy of antihyperglycemic regimens: a meta-analysis. Curr Med Res Opin. 2012 Jun;28(6):969-77. doi: 10.1185/03007995.2012.684045. Epub 2012 May 3.
- XIGDUO® XR PRESCRIBING INFORMATION FDALink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Related trials for Type 2 Diabetes Mellitus (T2DM)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
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.
Guang Wang principal investigator
Beijing Chao Yang Hospital
35 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 Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets and Dapagliflozin tablets and Metformin HCl extended-release tablets in people with Type 2 Diabetes Mellitus (T2DM), run by AstraZeneca at 35 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 23 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 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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?
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 in HbA1c from baseline (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06327815, which also lists 2 linked publications.
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 31 Oct 2025.