Phase -IV study to check the safety of fixed dose combination of dapagliflozin and saxagliptin in Indian Type 2 Diabetes Mellitus patients
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2021/02/031471
- Lead Sponsor
- AstraZeneca Pharma India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 196
1. Provision of signed and dated, written informed consent prior to any study specific procedures according to local Indian procedure.
2. Male and female patients aged > 18 and above
3. Documented history of type 2 diabetes mellitus with HbA1c level >7.0% and = 10% at screening visit
4. Patients who are on a stable dose of antidiabetic drugs (including on Metformin dose between 1000-2000mg) in the past 3 months
5. 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.
1. Known allergies or contraindication to the contents of the IP, dapagliflozin or saxagliptin tablets.
2. Active participation in another clinical study with IP and/or investigational device
3. For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
4. Type 1 diabetes mellitus.
5. Treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors at Visit 1 or 2
6. Patients with moderate to severe renal impairment (eGFR persistently <45 mL/min/1.73 m2 by CKD-EPI formula, or end-stage renal disease (ESRD) or ‘Unstable or rapidly progressing renal disease
7. Patients with severe hepatic impairment (Child-Pugh class C)
8. History of pancreatitis or pancreatic surgery
9.Patients with a history of any malignancy
10. 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.
11. History of heart failure
12. 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
13. History of diabetic ketoacidosis
14. Any acute/chronic systemic infections
15. Recurrent urogenital infections
16. Patients at risk for volume depletion as judged by the investigator
17. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- 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 (volume depletion, renal events, major hypoglycaemic events, fractures, urinary/genital tract infections, diabetic ketoacidosis, amputations and hospitalization for heart failure) <br/ ><br> <br/ ><br>• Safety laboratory values <br/ ><br>• Electrocardiogram (ECG) <br/ ><br>• Vital Signs (pulse and BP) <br/ ><br>• Physical examinationTimepoint: 24 weeks
- Secondary Outcome Measures
Name Time Method HbA1c change at week 24 compared to baseline. <br/ ><br> <br/ ><br>Weight change at week 24 compared to baseline. <br/ ><br> <br/ ><br>Systolic Blood Pressure (SBP) change at week 24 compared to baseline. <br/ ><br> <br/ ><br>FPG change at week 24 compared to baseline. <br/ ><br>Timepoint: 24 Weeks