Phase III, Randomized, Open Label,Parallel group, Multicentric clinical study
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2022/01/039154
- Lead Sponsor
- SV Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
therapy.
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.
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
the study.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in glycosylated hemoglobin (HbA1c) from baseline to end of the study visit (12 <br/ ><br>Weeks).Timepoint: Screeing / Baseline visit [V1] (Day -7) <br/ ><br>Randomization visit [V2] (Day 1) <br/ ><br>Follow up visit [V3] Week 2/Day 14(±2) <br/ ><br>Follow up visit [V4] Week 6/Day 42(±2) <br/ ><br>Final visit [V5] Week 12/Day 84 (±2)
- Secondary Outcome Measures
Name Time Method Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of the <br/ ><br>study visit.Timepoint: Follow up visit [V3] Week 2/Day 14(±2) <br/ ><br>Follow up visit [V4] Week 6/Day 42(±2) <br/ ><br>Final visit [V5] Week 12/Day 84 (±2)