Status:
COMPLETED
To Assess Safety of Fixed Dose Combination of Dapagliflozin and Saxagliptin in Type 2 Diabetes Mellitus Patients
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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. Elect...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2023
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT04445714
Start Date
April 7 2021
End Date
March 14 2023
Last Update
November 12 2024
Active Locations (9)
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1
Research Site
Bangalore, India, 560017
2
Research Site
Bhubaneswar, India, 751007
3
Research Site
Chandigarh, India, 160012
4
Research Site
Coimbatore, India, 641018