Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM
1 other identifier
interventional
633
1 country
35
Brief 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 with T2DM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2024
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2024
CompletedStudy Start
First participant enrolled
March 15, 2024
CompletedFirst Posted
Study publicly available on registry
March 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedOctober 31, 2025
October 1, 2025
1.3 years
February 19, 2024
October 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
24 weeks
Secondary Outcomes (6)
Proportion of patients achieved HbA1c less than 7.0% from baseline to week 24.
24 weeks
Absolute change in FPG from baseline to week 24.
24 weeks
Absolute change in PPG from baseline to week 24.
24 weeks
The difference in satisfaction scores between 2 groups measured with the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at week 24.
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.
Week 12 and Week 24
- +1 more secondary outcomes
Other Outcomes (17)
AEs
24 weeks
SAE
24 weeks
ADRs
24 weeks
- +14 more other outcomes
Study Arms (2)
Co-administered Dual Therapy
ACTIVE COMPARATORDapagliflozin tablets and Metformin HCl extended-release tablets
FDC Regimen of Dapagliflozin/Metformin XR
EXPERIMENTALXigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets
Interventions
10 mg Dapagliflozin/1000 mg Metformin HCl extended-release
Dapagliflozin tablets: 10 mg Metformin HCl extended-release tablets: 1000 mg
Eligibility Criteria
You may qualify if:
- 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).
- 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.
You may not qualify if:
- 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.
- 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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (35)
Research Site
Beijing, 100020, China
Research Site
Beijing, 100050, China
Research Site
Beijing, 100076, China
Research Site
Beijing, 102218, China
Research Site
Changsha, 410005, China
Research Site
Chengdu, 610072, China
Research Site
Chongqing, 402260, China
Research Site
Chuxiong, 675000, China
Research Site
Dalian, 116001, China
Research Site
Dingzhou, 562100, China
Research Site
Fuyang, 236400, China
Research Site
Guangzhou, 510180, China
Research Site
Guangzhou, 510515, China
Research Site
Guiyang, 550044, China
Research Site
Hefei, 230012, China
Research Site
Jiangyin, 214400, China
Research Site
Jiyuan, 459003, China
Research Site
Kunming, 650032, China
Research Site
Nanchang, 330006, China
Research Site
Nanning, China
Research Site
Nantong, 226001, China
Research Site
Panjin, 124000, China
Research Site
Qingdao, 266200, China
Research Site
Quanzhou, 362000, China
Research Site
Rui’an, 325200, China
Research Site
Shenzhen, 518101, China
Research Site
Suzhou, 215500, China
Research Site
Taiyuan, 030001, China
Research Site
Tianjin, 300134, China
Research Site
Weifang, 261035, China
Research Site
Wenzhou, 325000, China
Research Site
Wuhan, 430010, China
Research Site
Yibin, 610500, China
Research Site
Zhengzhou, 450052, China
Research Site
Zhuji, 311899, China
Related Publications (2)
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.
PMID: 27574406BACKGROUNDHan 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.
PMID: 22494018BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guang Wang
Beijing Chao Yang Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2024
First Posted
March 25, 2024
Study Start
March 15, 2024
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
October 31, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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.