Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Imeglimin Hydrochloride SR Tablets 1000 mg: Patients will be advised to take one tablet once a day orally, swallowed with water in the morning around same time every day for 16 weeks.
C
Sponsors
Exemed Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female Patients aged between 18 to 65 years (both inclusive) with diagnosis of Type 2 diabetes mellitus. 2. Treatment naïve patients with inadequately controlled with diet and exercise therapy alone for at least 3 months prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of > 7.0% to = 8.5%. 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
Exclusion criteria: 1. Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus. 2. Patients with a history of metabolic acidosis or diabetic ketoacidosis. 3. Patients with Fasting Plasma Glucose (FPG) > 200 mg/dL at screening (If FPG is > 200 mg/dL at screening, FPG will be repeated within 1 week. If repeat FPG is > 200 mg/dL, patient will be excluded from the study). 4. Patients with Estimated glomerular filtration rate (eGFR) 5. Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 2X the UNL) at screening. 6. Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure. 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. Patients with uncontrolled hypertension with sitting systolic BP = 160 mmHg and/or diastolic BP = 100 mmHg at screening. 9. 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 patient’s participation in the study. 10. Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin 11. Patients with known hypersensitivity to any of the ingredients of study medication. 12. Patients receiving treatment with systemic corticosteroids. 13. Pregnant or breast-feeding or expecting to conceive within the projected duration of the study. 14. 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). 15. Patients with history of any malignancy. 16. Patients with known case of infection with hepatitis B, hepatitis C or HIV. 17. Patients with donation or transfusion of blood, plasma, or platelets within the past 3 months prior to screening. 18. 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. 19. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent. 20. Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period. 21. Suspected inability or unwillingness to comply with the study procedures. 22. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in glycosylated haemoglobin (HbA1c) from baseline to end of the study visit (week 16).Timepoint: At Screening/baseline visit, Visit 5 [Week 12/Day 84 (±2)] and Visit 6 [Week 16/Day 112 (±2)]. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events / serious adverse events reported during the study.Timepoint: Throughout the study.;Changes in clinical laboratory parameters from baseline to end of the study visit (week 16).Timepoint: At Screening/baseline visit and Visit 6 [Week 16/Day 112 (±2)].;Hypoglycemic episodes during the study.Timepoint: Throughout the study.;Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of the study visit (week 16).Timepoint: At Screening/baseline visit, Visit 3 [Week 2/Day 14 (±2)], Visit 4 [Week 6/Day 42 (±2)], Visit 5 [Week 12/Day 84 (±2)] and Visit 6 [Week 16/Day 112 (±2)].;Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (week 16).Timepoint: At Screening/baseline visit, Visit 3 [Week 2/Day 14 (±2)], Visit 4 [Week 6/Day 42 (±2)], Visit 5 [Week 12/Day 84 (±2)] and Visit 6 [Week 16/Day 112 (±2)].;Proportion of patients achieving a therapeutic glycemic response, defined as HbA1c 7% at the end of the study visit (week 16).Timepoint: At Visit 6 [Week16 /Day 112(±2)].;Proportion of patients requiring rescue medication.Timepoint: At Visit 3 [Week 2/Day 14 (±2)], Visit 4 [Week 6/Day 42 (±2)], Visit 5 [Week 12/Day 84 (±2)] and Visit 6 [Week 16/Day 112 (±2)]. | — |
Countries
India
Contacts
Public ContactMr Mihir Upadhyay
Clinwave Research Pvt. Ltd.
Outcome results
None listed