Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Fixed dose combination
of Metformin, Sitagliptin, and
Dapagliflozin.: Fixed dose combination
of Metformin hydrochloride 1000 mg ER, Sitagliptin phosphate 100 mg and
Dapagliflozin Pr
Sponsors
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 glycaemic control to metformin �1500 mg/day for at least 6 weeks 4. Patients with HbA1c value between 8.0% and 10.0%
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to metformin, sitagliptin or dapagliflozin or to any of the excipients of the investigational products 2. Patients with BMI ââ?°Â¥ 40 kg/m2 3. Laboratory findings measured at screening: a. Creatinine clearance (eGFR) Disease 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 Investigatorââ?¬•s opinion precluding patientââ?¬•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 who are on dialysis 8. Patients with any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis etc.) 9. Patients with acute conditions with the potential to alter renal function such as dehydration, severe infection, shock, or intravascular administration of iodinated contrast agents 10. Patients with genital mycotic infections or urinary tract infections 11. Patients with hypotension requiring intervention 12. Patients who have used corticosteroids for one week or more within 3 months prior to screening 13. Patients with acute or chronic cardiovascular or respiratory disease including recent myocardial infarction, or shock within six months prior to randomization 14. Positive testing for HIV, hepatitis B (hepatitis B virus surface antigen [HBsAg]) or hepatitis C (hepatitis C virus antibody [HCV Ab]) virology 15. 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) or with history of travel / contact with any COVID-19 positive patient/isolation/quarantine 16. 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: 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) OR d. Females who are surgically sterile OR e. Females who are post-menopausal for at least one year 17. Pregnant or lactating women 18. Patients with clinically significant medical history, vital signs, physical examination 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 |
|---|---|
| ïâ??· Change in body weight from baseline to Week 16 ïâ??· Change in fasting plasma glucose (FPG) from baseline to Week 16 ïâ??· 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