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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: dapagliflozin and saxagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: For inclusion in the study subjects should fulfil the following criteria: Provision of signed and dated, written informed consent prior to any study specific procedures according to local Indian procedure. Male and female patients aged > 18 and above Documented history of type 2 diabetes mellitus with HbA1c level >7.0% and ≤ 10% at screening visit Patients who are on a stable dose of antidiabetic drugs (including on Metformin dose between 1000-2000mg) in the past 3 months Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used. Exclusion criteria: Known allergies or contraindication to the contents of the IP, dapagliflozin or saxagliptin tablets. Active participation in another clinical study with IP and/or investigational device For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding. Type 1 diabetes mellitus. Treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors at Visit 1 or 2 Patients with moderate to severe renal impairment (eGFR persistently <45 mL/min/1.73 m2 by CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula or end-stage renal disease (ESRD) or 'Unstable or rapidly progressing renal disease Patients with severe hepatic impairment (Child-Pugh class C) History of pancreatitis or pancreatic surgery Patients with a history of any malignancy Patients with any of the following CV/Vascular Diseases within 3 months prior to signing the consent at enrolment, as assessed by the investigator: Myocardial infarction. Cardiac surgery or revascularization (CABG/PTCA). Unstable angina. Transient ischemic attack (TIA) or significant cerebrovascular disease. Unstable or previously undiagnosed arrhythmia. History of heart failure Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg at any visit up to randomisation History of diabetic ketoacidosis Any acute/chronic systemic infections Recurrent urogenital infections Patients at risk for volume depletion as judged by the investigator Any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient or patient suspected or with confirmed poor protocol or medication compliance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: dapagliflozin and saxagliptin<br>Singe arm once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally | Drug: dapagliflozin and saxagliptin<br>* Combination of dapagliflozin and saxagliptin tablet once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally<br>* Other names: QTERN Tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients | Number, frequency and percentages of incidence of adverse events (AEs) and serious adverse events (SAEs) | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients | Mean change in Glycated haemoglobin (HbA1c) from baseline to 6 months | 6 Months |