Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: FDC of Empagliflozin 10 mg + Sitagliptin 100 mg + Metformin Hydrochloride ER 1000 mg Tablets: Patients will be advised to take one tablet once a day orally, swallowed with water in the
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.Patients along with diet and exercise control, additionally on the stable dose of Metformin IR or ER greater than or equal to 1500 mg per day (greater than 1000 mg per day for subjects not tolerating) as monotherapy for at least 8 weeks prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of greater than or equal to 8.5% to less than or equal to 11.0%. 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 or baseline visit. 4.Patients with no abnormality on 12-lead ECG at screening or baseline visit. 5.Patient with ability to understand and provide written, signed and dated informed consent form, which must have been obtained prior to screening. 6.Patients willing to comply with all 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 a history of bariatric surgery or lap-band procedure within 12 months prior to screening. 4.Patients with Fasting Plasma Glucose (FPG) greater than 270 mg per dL at screening. 5.Patients with the Body Mass Index (BMI) greater than or equal to 45.0 kg per m2 at screening. 6.Patients with Estimated glomerular filtration rate (eGFR) less than 60 mL per min per 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 2X the UNL) at screening. 8.Patients taking loop diuretics within one week prior to screening or planning to take during the study. 9.Patients with history of taking any weight loss medications within 3 months prior to randomization. 10.Patients with treatment of glucocorticoids equivalent to oral Prednisolone greater than or equal to 10 mg (Betamethasone greater than or equal to 1.2 mg, Dexamethasone greater than or equal to 1.5 mg, Hydrocortisone greater than or equal to 40 mg) per day within 30 days prior to randomization; topical, nasal or inhaled corticosteroids are allowed. 11.Patients suffering with end-stage renal disease or on dialysis. 12.Patients suffering from severe urinary tract infections (e.g., urosepsis, pyelonephritis), necrotizing fasciitis of the Perineum (Fournier’s Gangrene), intravascular volume contraction and/or female genital mycotic infections prior to 6 months from screening. 13.Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure. 14.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. 15.Patients with any condition (e.g., infection, trauma and surgery) which require insulin therapy at the time of screening or during the study period. 16.Patients with history or currently suffering with severe and disabling arthralgia. 17.Patients with history or currently suffering with bullous pemphigoid requiring hospitalization and taking DPP-4 inhibitors. 18.Patients with history of inflammatory bowel disease or intestinal ulcers or chronic enteric diseases related to digestion and absorption. 19.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. 20.Patients with 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. 21.Patients with history of hereditary QT prolongation syndrome or patients having history of Torsades de pointes. 22.Patients who are accepting treatments of arrhythmias. 23.Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin less than 10 g per dL for men; haemoglobin less than 9 g/dL for women at
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 or Baseline visit (Day -7), Follow up visit / Week 12 (Day 84±3) and End of the study visit / Week 16 (Day 112±3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (week 16).Timepoint: At Screening or Baseline visit (Day -7), Follow up visit / Week 2 (Day 14±3), Follow up visit / Week 6 (Day 42±3), Follow up visit / Week 12 (Day 84±3) and End of the study visit / Week 16 (Day 112±3). ;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 or Baseline visit (Day -7), Follow up visit / Week 2 (Day 14±3), Follow up visit / Week 6 (Day 42±3), Follow up visit / Week 12 (Day 84±3) and End of the study visit / Week 16 (Day 112±3). ;Proportion of patients achieving a therapeutic glycemic response, defined as HbA1c less than 7% at the end of the study visit (week 16).Timepoint: At Screening or Baseline visit (Day -7), Follow up visit / Week 12 (Day 84±3) and End of the study visit / Week 16 (Day 112±3). ;Mean change in body weight from baseline to end of the study visit (week 16).Timepoint: At Screening or Baseline visit (Day -7), Follow up visit / Week 2 (Day 14±3), Follow up visit / Week 6 (Day 42±3), Follow up visit / Week 12 (Day 84±3) and End of the study visit / Week 16 (Day 112±3). ;Mean change in systolic blood pressure (SBP) from baseline to end of the study visit (week 16).Timepoint: At Screening or Baseline visit (Day -7), Randomization visit (Day 1), Follow up visit / Week 2 (Day 14±3), Follow up visit / Week 6 (Day 42±3), Follow up visit / Week 12 (Day 84±3) and End of the study visit / Week 16 (Day 112±3). ;Adverse events and or serious adverse events reported during the study.Timepoint: Throughout the study. | — |
Countries
India
Contacts
Public ContactMr Mihir Upadhyay
Clinwave Research Pvt. Ltd.
Outcome results
None listed