Trial · NCT06327815
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| 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. |
| Other | Temperature | 24 weeks | Armpit Temperature. |
| Other | Systolic and diastolic BP | 24 weeks | Blood pressure should be measured with a completely automated device in triplicate with at least 1-minute intervals between measurements after being comfortably at rest in a seated position(mmHg). |
| Other | Pulse rate | 24 weeks | Pulse rate should be measured with a completely automated device in triplicate with at least 1-minute intervals between measurements after being comfortably at rest in a seated position(times/min) |
| Other | Respiratory rate | 24 weeks | Respiratory rate per minute(times/min) |
| Other | Weight | 24 weeks | Weight in kilograms |
| Other | Height | 24 weeks | Height in meters |
| Other | BMI | 24 weeks | BMI in kg/m\^2 |
| Other | Number of participants with abnormal ECG readings | 24 weeks | The normality/abnormality of ECG tracings, as determined by the Investigator. |
| Other | Proportion of TITR (Time in Tight Target Range) | Week 12 | The percentage of readings and time that a person spends with their blood glucose levels in a Tight target range (3.9-7.8mmol/L). |
| Other | TIR (Time In Range) | Week 12 | The percentage of readings and time that a person spends with their blood glucose levels in a target range (3.9-10mmol/L). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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