Effectiveness and Safety of a New Diabetes Medication with Conventional Treatment in Patients with Type 2 Diabetes

Phase 3

Conditions: Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

Registration Number: CTRI/2024/02/062299

Lead Sponsor: Eris Lifesciences Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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 mono therapy - to be enrolled and continue them with dual therapy.i.e Patients with HbA1C level greater than or equal to 7.5% to 10% and who are presently on greater than or equal to 1000 mg-day Metformin for at least 3 months prior to screening

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 the Body Mass Index (BMI) greater than or equal to 45.0 kg-m2 at screening

5. Patients with Fasting Plasma Glucose (FPG) greater-than 240 mg-dL at screening or randomization

6. Patients with Estimated glomerular filtration rate (eGFR) less-than sign 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. Laboratory findings measured at screening:

a) Neutrophils less-than sign 2000 mm3

b) Platelets less-than sign100,000 mm3

c) Total bilirubin greater-than 1.5 X ULN

d) ALT- AST greater-than 2.5 X ULN

e) Serum amylase and-or lipase greater-than 3 X ULN

f) Any other screening laboratory value that is clinically significant in the Investigator’s opinion precluding patient’s participation in the study.

10. Patients with a history of anaemia or haemoglobinopathy and-or haemoglobin less-than sign 10 g dL for men; haemoglobin less-than sign 9 g dL for women at screening.

11. Patients with uncontrolled hypertension with sitting systolic BP greater than or equal to 160 mmHg and-or diastolic BP greater than or equal to 100 mmHg at screening.

12. Pregnant or breast-feeding or expecting to conceive within the projected duration of the study.

13. Patients with known case of infection with hepatitis B, hepatitis C or HIV

14. Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.

15. Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.

16. Suspected inability or unwillingness to comply with the study procedures.

17. 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
Evaluate mean change in HbA1c levels from baseline compared to end of study visit-week 16Timepoint: Below mentioned visit and times lines <br/ ><br>Visit 1. Screening Visit Days -7 to Day 0 <br/ ><br>Visit 2. Randomization-Baseline Visit Day 0 <br/ ><br>Visit 3. Interim Visit Week 2Day 14 ± 3 days <br/ ><br>Visit 4. Interim Visit Week 4-Day 28 ± 3 days <br/ ><br>Visit 5. Interim Visit Week 8-Day 56 ± 3 days <br/ ><br>Visit 6. End of Study-Early Discontinuation Visit Week 12-Day 84 ± 3 days <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Evaluate mean change in Fasting Plasma Glucos levels from baseline at the end of Week 2, 4, 8, and 12. <br/ ><br>Evaluate mean change in 2-hour post prandial blood glucose levels from baseline at the end of Week 2, 4, 8, and 12. <br/ ><br>Evaluate percentage of patients with HbA1c levels less-than 7.5% at end of study visit-week 12 <br/ ><br>Timepoint: Below mentioned visit and times lines <br/ ><br>Visit 1. Screening Visit Days -7 to Day 0 <br/ ><br>Visit 2. Randomization-Baseline Visit Day 0 <br/ ><br>Visit 3. Interim Visit Week 2Day 14 ± 3 days <br/ ><br>Visit 4. Interim Visit Week 4-Day 28 ± 3 days <br/ ><br>Visit 5. Interim Visit Week 8-Day 56 ± 3 days <br/ ><br>Visit 6. End of Study-Early Discontinuation Visit Week 12-Day 84 ± 3 days <br/ ><br>