Trial · NCT06327815
Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM
NCT06327815, Phase 4, Completed, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM. Trials, record NCT06327815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06327815
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT06327815
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 633 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Interventions
- Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets, Dapagliflozin tablets and Metformin HCl extended-release tablets
- First posted
- 2024-03-25
- Last updated
- 2025-10-31
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in HbA1c from baseline | 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. |
| Secondary | Proportion of patients achieved HbA1c less than 7.0% from baseline to week 24. | 24 weeks | To describe the changes from baseline at Week 24 in proportion of patients with HbA1c \< 7%. |
| Secondary | Absolute change in FPG from baseline to week 24. | 24 weeks | To describe the changes from baseline at Week 24 in fasting plasma glucose (FPG). |
| Secondary | Absolute change in PPG from baseline to week 24. | 24 weeks | To describe the changes from baseline at Week 24 in postprandial glucose (PPG). |
| Secondary | The difference in satisfaction scores between 2 groups measured with the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at week 24. | 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. |
| Secondary | 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 | 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. |
| Secondary | 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. | Week 24 | 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. |
| Other | AEs | 24 weeks | An AE can therefore be any unfavourable and unintended sign (eg, an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether it's considered related to the medicinal product. |
| Other | SAE | 24 weeks | An SAE is an AE occurring during any study phase (i.e., run-in, treatment, washout, follow up), that fulfils one or more of the following criteria: Results in death. Is immediately life-threatening. Requires in-patient hospitalization or prolongation of existing hospitalization. Results in persistent or significant disability or incapacity. Is a congenital anomaly or birth defect. Is an important medical event that may jeopardize the participant or may require medical treatment to prevent one of the outcomes listed above. |
| Other | ADRs | 24 weeks | An Adverse Drug Reaction (ADR) is an Adverse Event suspected to be causally related to the medicinal product. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06327815
GET https://conductscience.org/api/trials/v1/NCT06327815/registered?page=2