CTRI/2022/01/039154Active, not recruitingPhase 3
A Phase III, Prospective, Randomized, Open Label, Active Controlled, ParallelGroup, Multicenter Clinical Study to Evaluate the Efficacy, Safety andTolerability of a Fixed Dose Combination of Vildagliptin and DapagliflozinTablets 50mg/5mg of USV Private Limited., India as compared to ConcomitantAdministration of Reference Product, Galvus® 50mg tablets (Vildagliptin) ofNovartis Pharmaceuticals UK Ltd., along with Forxiga® 5 mg tablets(Dapagliflozin) of AstraZeneca Pharmaceuticals, USA in Patients with Type 2Diabetes Mellitus Inadequately Controlled on earlier metformin containing dualtherapy. - FDC of Vildagliptin and dapagliflozin
SV Pvt Ltd0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Male or Female Patients aged between 18 to 65 (both inclusive) years with diagnosis
- •of Type 2 diabetes mellitus.
- •2. Patients who have ongoing dual therapy - to be enrolled and continue them with triple
- •i.e Patients with HbA1C level >= 7.5% to 10%.and who are presently on (Metformin +
- •Vildagliptin ) or (Metformin + Dapagliflozin)
- •3. Women of childbearing potential (WOCBP) must be using an acceptable method of
- •contraception to avoid pregnancy throughout the study. WOCBP must have a negative
- •urine pregnancy test at screening / baseline visit.
- •4. Patients with no abnormality on 12-lead ECG at screening / baseline visit.
- •5. Patient with ability to understand and provide written informed consent form, which
- •must have been obtained prior to screening.
- •6. Patients willing to comply with the protocol requirements.
Exclusion Criteria
- •1. Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or
- •diabetes insipidus.
- •2. Subjects with symptomatic urinary tract infection or mycotic genital infection at screening
- •or history of a recent symptomatic infection within 4 weeks prior to screening
- •3. Patients with a history of metabolic acidosis or diabetic ketoacidosis.
- •4. Patients with Fasting Plasma Glucose (FPG) > 220 mg/dL at screening (If FPG is >
- •220 mg/dL at screening, FPG will be repeated within 1 week. If repeat FPG is > 220
- •mg/dL, patient will be excluded from the study).
- •5. Patients with the Body Mass Index (BMI) >= 45.0 kg/m2 at screening.
- •6. Patients with Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2
- •[using the Modification of Diet in Renal Disease (MDRD) equation] at screening.
- •7. Patients with clinically significant impaired hepatic function (SGOT & SGPT more
- •than 3X the UNL and/or Total bilirubin more than 1.5X the UNL) at screening.
- •8. Patients with a history of congestive heart failure defined as New York Heart
- •Association (NYHA) class III/IV, unstable or acute congestive heart failure.
- •9. Patients with significant cardiovascular history defined as: myocardial infarction,
- •unstable angina pectoris, transient ischemic attack, unstable or previously
- •undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty
- •or bypass grafts), or cerebrovascular accident.
- •10. Patients with uncontrolled hypertension with sitting systolic BP >= 160 mmHg and/or
- •diastolic BP >= 100 mmHg at screening.
- •11. Any abnormality on 12-lead ECG at screening that in the opinion of the investigator
- •is clinically significant and is judged as potential risk for patientâ??s participation in
- •the study. For male patients with mean QTcB >= 450 msec or female patients with
- •mean QTcB >= 470 msec, triplicate ECG will be performed. If mean QTcB is >= 450
- •msec in males or mean QTcB is >= 470 msec in females on triplicate ECG, patient
- •will be excluded from the study.
- •12. Patients with history of hereditary QT prolongation syndrome or patients having
- •history of Torsades de pointes.
- •13. Patients who are accepting treatments of arrhythmias.
- •14. Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin < 10
- •g/dL for men; haemoglobin < 9 g/dL for women at screening.
- •15. Patients with known history of acute pancreatitis.
- •16. Patients with a history of treatment with estrogens and other medications known to
- •affect bone.
- •17. Patients with history of clinically significant peripheral edema in past 6 months.
- •18. Patients with intolerance, contraindication or potential allergy/hypersensitivity to
- •any of the ingredients of study medication or any other DPP4 inhibitors or
- •thiazolidinediones.
- •19. Pregnant or breast-feeding, or expecting to conceive within the projected duration of
- •20. Female patients who are of childbearing potential and who are neither surgically
- •sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier
- •methods or intrauterine device).
- •21. Patients with history of any malignancy.
- •22. Patients with known case of infection with hepatitis B, hepatitis C or HIV. <br
Investigators
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