Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Fixed dose combination of Dapagliflozin and Linagliptin: Fixed dose combination of Dapagliflozin 10 mg and Linagliptin 5 mg . Treatment Duration 16 weeks to be taken orally once daily a
Sponsors
Alkem Laboratories Limited
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing to provide voluntary written informed consent and able to comply with the protocol requirements 2. Male or female patients with Type 2 DM of 18 to 65 years of age (both inclusive) 3. Patients who have inadequate glycemic control to metformin monotherapy >=1000 mg/day for at least 6 weeks 4. Patients with HbA1c value between 7.5 % and 10.5 %
Exclusion criteria
Exclusion criteria: The patients will be excluded from the study based on the following criteria: 1. Known hypersensitivity to Linagliptin or Dapagliflozin or to any of the excipients of the investigational products 2. Patients with BMI >= 40 kg/m2 3. Laboratory findings measured at screening a. eGFR Epidemiology Collaboration) equation b. Hemoglobin c. Neutrophils d. Platelets e. Total bilirubin > 1.5 X ULN f. ALT/ AST > 2.5 X ULN g. Serum amylase and/or lipase > 3 X ULN h. Any other screening laboratory value that is clinically significant in the Investigatorâ??s opinion precluding patientâ??s participation in the study 4. Patients with Type 1 DM 5. Patients with fasting plasma glucose of > 270 mg/dL 6. Patients with hypothyroidism or hyperthyroidism 7. Patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease 8. Patients who are on dialysis 9. Patients with any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis etc.) 10. Patients with acute conditions with the potential to alter renal function such as dehydration, severe infection, shock, or intravascular administration of iodinated contrast agents 11. Patients with history of pancreatitis 12. Patients with pancreatic insulin deficiency from any cause, caloric restriction, or are alcohol abuse 13. Patients with genital mycotic infections or urinary tract infections 14. Patients with hypotension requiring intervention 15. Patients who have used corticosteroids for one week or more within 3 months prior to screening 16. Patients with a prior history of heart failure 17. Positive testing for HIV, hepatitis B (hepatitis B virus surface antigen [HBsAg]) or hepatitis C (hepatitis C virus antibody [HCV Ab]) virology 18. Patients who had suffered from COVID-19 within 8 weeks prior to study drug administration or patients with suspected signs and symptoms of COVID-19/ confirmed novel coronavirus infection (COVID-19) 19. Women of child bearing potential not practicing any acceptable methods of contraception during study. For this study, acceptable and effective methods of contraception for females include at least one of the following: a. Intrauterine device placed at least 6 months prior to the first study dose and agree to follow throughout the study b. Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) c. Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner) d. Females who are surgically sterile e. Females who are post-menopausal for at least one year 20. Pregnant or lactating women 21. Patients with clinically significant medical history, vital signs, physical examination requiring exclusion of the patient as deemed by the investigator or designee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c levels from baseline to Week 16Timepoint: Baseline to 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in body weight from baseline to Week 16 Change in fasting plasma glucose (FPG) from baseline to Week 16 Change in post-prandial blood glucose (PPG) levels from baseline to Week 16Timepoint: Baseline to 16 weeks | — |
Countries
India
Contacts
Public ContactDr Vinayaka Shahavi
Alkem Laboratories Limited
Outcome results
None listed