A clinical trial to study the efficacy and safety of fixed dose combination of remogliflozin etabonate and teneligliptin in the treatment of type 2 diabetes mellitus.
Phase 3
Completed
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2020/04/024841
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
This study is a randomized, double blind, double dummy, active controlled, parallel group, multi-center trial comparing the safety and efficacy of FDC of remogliflozin etabonate (100 mg) and teneligliptin (10 mg) given twice daily with that of teneligliptin (20 mg) once daily in 308 patients who have inadequately controlled type 2 diabetes mellitus on stable dose of metformin for at least 10 weeks. The subjects will continue to receive metformin at stable doses of ≥ 1500 mg per day, throughout the study period in an open label manner. The study consists of screening period of up to 3 weeks (including 2 week run in period), 16 weeks study treatment and a safety follow up period of 2 weeks post last dose of the study drug. The primary outcome measures will be mean change from baseline in HbA1c at the end of treatment. Any adverse event (AE), either clinical/laboratory, will be recorded and assessed for severity, seriousness and causality.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 308
Inclusion Criteria
- Male and female subjects ≥18 and ≤ 65 years of age, diagnosed with T2DM.
- Subjects who have received stable dose of metformin ≥1500 mg/day as monotherapy for at least 10 weeks prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of ≥8% to ≤11%.
- Subjects must be willing and able to provide written informed consent.
- Willing and able to comply with all aspects of the protocol.
- Must be willing to use a highly effective form of contraception (with pearl index < 1%) e.g. double barrier method, for the duration of the study.
- Methods like periodic abstinence, post ovulation procedures and withdrawal are not considered adequate.
- Oral contraceptive pills are not allowed due to potential of drug interaction with investigational product.
- If the subject is a female of childbearing potential, the result of a urine pregnancy test at screening must be negative.
- Each female will be considered to have childbearing potential unless surgically sterilized by hysterectomy or has been post-menopausal for at least 2 years.
Exclusion Criteria
- History of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus History of metabolic acidosis or diabetic ketoacidosis FPG >270 mg/dL at screening.
- If FPG is >270 mg/dL at screening, FPG will be repeated within 1 week.
- If repeat FPG is >270 mg/dL, subject will be excluded from the study.
- BMI ≥45.0 kg/m2 at screening Subjects with elevated thyroid stimulating hormone (TSH) level at screening with or without thyroid hormone replacement therapy Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 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 Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3X ULN or total serum bilirubin >2.0 mg/dL at screening Congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.
- 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.
- Subjects with uncontrolled hypertension with sitting systolic BP ≥160 mmHg and/or diastolic BP ≥ 100 mmHg at screening.
- Note: Subjects with SBP ≥ 160mmHg and < 180mmHg or a DBP ≥ 100 mmHg and < 110mmHg will be able to enter the run-in period, provided their hypertension treatment is adjusted as deemed appropriate by the investigator.
- These subjects cannot be randomized if they meet the blood pressure exclusion criterion of SBP ≥ 160 mmHg or DBP ≥ 100 mmHg measured at randomization visit.
- 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 subject’s participation in the study.
- For male subjects with mean QTcB ≥450 msec or female subjects 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, subject will be excluded from the study.
- Patients with history of hereditary QT prolongation syndrome or patients having history of Torsades de pointes.
- Patients with history of abdominal surgery or intestinal obstruction.
- Patients with history of acute pancreatitis.
- History of anaemia or haemoglobinopathy and/or haemoglobin <10 g/dL (<100 g/L) for men; haemoglobin <9 g/dL (<90 g/L) for women at screening Donation or transfusion of blood, plasma, or platelets within the past 3 months prior to enrolment History of malignancy within the last 5 years prior to enrolment, excluding non-melanoma skin cancer (e.g. basal or squamous cell skin carcinoma) or treated carcinoma-in-situ of cervix Intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or any other SGLT2 inhibitors or DPP4 inhibitors Subjects with symptomatic diarrhoea or any other medical condition which the investigators may judge to be a risk for dehydration and hypovolemia Subjects with symptomatic urinary tract infection or mycotic genital infection at screening or history of a recent symptomatic urogenital infection within 4 weeks prior to screening Subject with a positive result for hepatitis B surface antigen or hepatitis C antibody at screening.
- Subject is known to be seropositive for human immunodeficiency virus (HIV).
- Subject not willing to comply with dietary and exercise plan provided at screening.
- Subject with any condition which, in the judgment of the Investigator, may render the subject unable to complete the study or which may pose a significant risk to the subject.
- Employee of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
- Concurrent enrollment in another interventional clinical study.
- Pregnant or breastfeeding women Subjects with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the subject’s participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change from baseline in HbA1c levels at week 16 16 Weeks
- Secondary Outcome Measures
Name Time Method Mean change from baseline in HbA1c levels 12 weeks Mean change from baseline in post-prandial plasma glucose (PPG) 16 weeks Mean change from baseline in fasting plasma glucose (FPG) levels at week 16 weeks Mean change from baseline in body weight 16 weeks Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c 7%. 16 weeks Proportion of subjects requiring rescue medication for hyperglycaemia During study treatment
Trial Locations
- Locations (27)
Anand Multispecialty Hospital
🇮🇳Vadodara, GUJARAT, India
Apex Hospital Pvt. Ltd.
🇮🇳Jaipur, RAJASTHAN, India
Apollo Hospital International Ltd.
🇮🇳Gandhinagar, GUJARAT, India
Ashirwad Hospital & Research Centre
🇮🇳Thane, MAHARASHTRA, India
Bangalore Diabetes Centre
🇮🇳Bangalore, KARNATAKA, India
BGS Global Institute of Medical sciences
🇮🇳Bangalore, KARNATAKA, India
Brij Medical Centre Pvt. Ltd.
🇮🇳Nagar, UTTAR PRADESH, India
CIMETs Inamdar Multispeciality Hospital
🇮🇳Pune, MAHARASHTRA, India
Diabetes Thyroid & Endocrine Centre
🇮🇳Jaipur, RAJASTHAN, India
Eternal Hospital, Unit of Eternal Heart Care Centre and Research Institute Pvt.Ltd.
🇮🇳Jaipur, RAJASTHAN, India
Scroll for more (17 remaining)Anand Multispecialty Hospital🇮🇳Vadodara, GUJARAT, IndiaDr Anand PatelPrincipal investigator9825652651amhbaroda@gmail.com