A prospective, multicenter, phase -IV study to assess the safety of fixed dose combination of dapagliflozin and saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients.
During the study, an AstraZeneca representative/delegate will have regular contacts with the study site, including visits to site for the site monitoring and source data verification activities. Electronic Case Report Forms (eCRF) will be used for data collection and query handling. The investigator will sign the completed electronic Case Report Forms. A copy of the completed electronic Case Report Forms will be archived at the study site. Authorized representatives of AstraZeneca or delegate, a regulatory authority, or an Ethics Committee may perform audits or inspections at the center's. Number and percentages of Incidence of adverse events will be presented, stratified by age/gender/baseline medications. Annualised event rate shall also be presented in addition to the incidence rate during the study. Mean change in HbA1C from baseline to 6 months for patients will be analysed using paired t test / Wilcoxon signed-rank test at 5% level of significance.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
196
Combination of dapagliflozin and saxagliptin tablet once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally
Research Site
Bangalore, India
Research Site
Bhubaneswar, India
Research Site
Chandigarh, India
Research Site
Coimbatore, India
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)
Time frame: 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.
Time frame: 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: 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).
Time frame: 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.
Time frame: Enrolment (Week -1) to End of Study (Week 26)
Glycated Haemoglobin (HbA1c) Change at Week 24 Compared to Baseline
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Research Site
Hyderabad, India
Research Site
Kolkata, India
Research Site
Lucknow, India
Research Site
Mohali, India
Research Site
New Delhi, India
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 24