| Trial ID: | L3506 |
| Source ID: | NCT04445714
|
| Associated Drug: |
Dapagliflozin And Saxagliptin
|
| Title: |
To Assess Safety of Fixed Dose Combination of Dapagliflozin and Saxagliptin in Type 2 Diabetes Mellitus Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT04445714/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: dapagliflozin and saxagliptin
|
| Outcome Measures: |
Primary: Adverse Events (AEs) Including Serious Adverse Events (SAEs), AEs Leading to Discontinuation (DAE), and Adverse Events of Special Interest, Adverse events (AEs) including serious adverse events (SAEs), AEs leading to discontinuation (DAE), and adverse events of special interest (volume depletion, renal events, major hypoglycemic events, fractures, urinary/genital tract infections diabetic ketoacidosis, amputations and hospitalization for heart failure), Baseline to End of Study (Week 26)|Clinically Important or Significant Abnormalities in Safety Laboratory Values, Clinical laboratory results were presented separately for haematology, clinical chemistry, and urinalysis variables. The number of participants with clinically important (haematology and clinical chemistry) or clinically significant (urinalysis) abnormalities in safety laboratory values are presented., Enrolment (Week -1) to End of Study (Week 26)|Clinically Important Abnormalities in ECG Values, The number of participants with clinically important abnormalities in ECG values are presented., Time Frame: Baseline to End of Study (Week 26)|Clinically Important Abnormalities in Vital Signs (Pulse and Blood Pressure), The number of participants with clinically important abnormalities in vital signs (pulse and blood pressure)., Enrolment (Week -1) to End of Study (Week 26)|Clinically Significant Abnormalities in Physical Examinations, The number of participants with clinically significant abnormalities in physical examinations., Enrolment (Week -1) to End of Study (Week 26) | Secondary: Glycated Haemoglobin (HbA1c) Change at Week 24 Compared to Baseline, The efficacy of the fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus participants was analyzed by measuring HbA1c change at week 24 compared to baseline., Baseline to Week 24|Weight Change at Week 24 Compared to Baseline, The efficacy of the fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus participants was analyzed by measuring weight change at week 24 compared to baseline., Baseline to Week 24|Systolic Blood Pressure Change at Week 24 Compared to Baseline, The efficacy of the fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus participants was analyzed by measuring systolic blood pressure change at week 24 compared to baseline., Baseline to Week 24|Fasting Plasma Glucose Change at Week 24 Compared to Baseline, The efficacy of the fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus participants was analyzed by measuring fasting plasma glucose change at week 24 compared to baseline., Baseline to Week 24
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| Sponsor/Collaborators: |
Sponsor: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
196
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-04-07
|
| Completion Date: |
2023-03-14
|
| Results First Posted: |
2024-11-12
|
| Last Update Posted: |
2024-11-12
|
| Locations: |
Research Site, Bangalore, 560017, India|Research Site, Bhubaneswar, 751007, India|Research Site, Chandigarh, 160012, India|Research Site, Coimbatore, 641018, India|Research Site, Hyderabad, 500024, India|Research Site, Kolkata, 700020, India|Research Site, Lucknow, 226003, India|Research Site, Mohali, 160062, India|Research Site, New Delhi, 110076, India
|
| URL: |
https://clinicaltrials.gov/show/NCT04445714
|
