To Assess Safety of Fixed Dose Combination of Dapagliflozin and Saxagliptin in Type 2 Diabetes Mellitus Patients

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: dapagliflozin and saxagliptin

Registration Number: NCT04445714

Lead Sponsor: AstraZeneca

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 196

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dapagliflozin and saxagliptin	dapagliflozin and saxagliptin	Singe arm once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally

Primary Outcome Measures

Name	Time	Method
Adverse Events (AEs) Including Serious Adverse Events (SAEs), AEs Leading to Discontinuation (DAE), and Adverse Events of Special Interest	Baseline to End of Study (Week 26)	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)
Clinically Important or Significant Abnormalities in Safety Laboratory Values	Enrolment (Week -1) to End of Study (Week 26)	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.
Clinically Important Abnormalities in ECG Values	Time Frame: Baseline to End of Study (Week 26)	The number of participants with clinically important abnormalities in ECG values are presented.
Clinically Important Abnormalities in Vital Signs (Pulse and Blood Pressure)	Enrolment (Week -1) to End of Study (Week 26)	The number of participants with clinically important abnormalities in vital signs (pulse and blood pressure).
Clinically Significant Abnormalities in Physical Examinations	Enrolment (Week -1) to End of Study (Week 26)	The number of participants with clinically significant abnormalities in physical examinations.

Secondary Outcome Measures

Name	Time	Method
Glycated Haemoglobin (HbA1c) Change at Week 24 Compared to Baseline	Baseline to Week 24	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.
Weight Change at Week 24 Compared to Baseline	Baseline to Week 24	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.
Systolic Blood Pressure Change at Week 24 Compared to Baseline	Baseline to Week 24	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.
Fasting Plasma Glucose Change at Week 24 Compared to Baseline	Baseline to Week 24	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.