A Study to Evaluate the Efficacy and Safety of Linagliptin plus Dapagliflozin Tablets in Patients with Type 2 Diabetes Mellitus not Controlled on Metformin.
- Conditions
- Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
- Registration Number
- CTRI/2023/02/049931
- Lead Sponsor
- Synokem Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or female patients aged between 18 to 65 years (bothinclusive) with diagnosis of Type 2 diabetes mellitus.
2. Patients along with diet and exercise control, additionally on thestable dose of Metformin >= 1000 mg/day as monotherapy for at least 6 weeks prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of >= 8.0% to <= 10.0%.
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 / 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. 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) > 270 mg/dL at screening.
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 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 >= 10 mg (Betamethasone >= 1.2 mg, Dexamethasone >= 1.5 mg, Hydrocortisone >= 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 (Fournierâ??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 >= 160 mmHg and/or diastolic BP >= 100 mmHg at screening.
20. 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.
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 < 10 g/dL for men; haemoglobin < 9 g/dL for women at screening.
24. Patients with known history of acute pancreatitis.
25. Patients with intolerance, contraindication or potential allergy/hypersensitivity to an
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in glycosylated haemoglobin (HbA1c) from baseline to end of the study visit. <br/ ><br>Timepoint: week 16
- Secondary Outcome Measures
Name Time Method Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (week 16). <br/ ><br>â?¢ Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of the <br/ ><br>study visit (week 16). <br/ ><br>â?¢ Proportion of patients achieving a therapeutic glycemic response, defined as HbA1c 7% at <br/ ><br>the end of the study visit (week 16). <br/ ><br>â?¢ Mean change in body weight from baseline to end of the study visit (week 16).Timepoint: Week 16