Phase III Randomized Open Label Parallel Multicentric clinical study
- Conditions
- Health Condition 1: - Health Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2022/07/044440
- Lead Sponsor
- SV Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 202
1. Male or Female Patients aged between 18 to 65 (both inclusive) years with diagnosis of
Type 2 diabetes mellitus at the time of informed consent.
2. Patients who are presently on Metformin dual therapy (i.e. a combination of Metformin
500mg with Vildagliptin 50 mg or Dapaglifloxin 5 mg BID, for at least 12 weeks prior
to screening and having HbA1c levels of >= 7.5 % to <= 10% at screening/baseline.
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
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 the Body Mass Index (BMI) >= 45.0 kg/m2 at screening
5. Patients with Fasting Plasma Glucose (FPG) > 240 mg/dL at screening or randomization
6. Patients with Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 [using
the Modification of Diet in Renal Disease (MDRD) equation] or serum creatinine level
of 1.5 mg/dL for male subjects and 1.4 mg/dL for female subjects at screening.
7. 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.
8. Intolerance, contraindication or potential allergy/hypersensitivity to any of the
ingredients of study medication or any other SGLT2 or DPP4 inhibitors
9. 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
10. Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin < 10 g/dL
for men; haemoglobin < 9 g/dL for women at screening.
11. Pregnant or breast-feeding, or expecting to conceive within the projected duration of the
study.
12. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
13. Patients with a history of substance abuse or dependence that in the opinion of the
Investigator is considered to interfere with the patientâ??s participation in the study.
14. Patients with concurrent participation in another clinical trial or any investigational
therapy within 90 days prior to signing informed consent.
15. Suspected inability or unwillingness to comply with the study procedures
16. Patient with 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method