Study to evaluate safety and efficacy of Dapagliflozin and Saxagliptin in patients with type 2 diabetes mellitus (T2DM) aged 10 to below 18 years old

Exclusion Criteria

• -Target Disease Exceptions
• -Presence of Type 1 diabetes, as demonstrated by Preexisting diagnosis of Type 1 diabetes,
• -Previous diagnosis of monogenic etiology of Type 2 diabetes
• -Diabetes ketoacidosis (DKA) within 6 months of screening
• -Current use of the following medications for the treatment of diabetes, or use within the specified timeframe prior to screening for the main study:
• -Eight weeks: sulfonylureas, alpha glucosidase inhibitors, metiglinide, oral or injectable incretins or incretin mimetics, other antidiabetes medications not otherwise specified.
• -Sixteen weeks: thiazolidinediones, DPP-4 inhibitors (with no reported medication related AEs related to DPP-4 inhibitors), sodium glucose cotransporter-2 (SGLT-2) inhibitors (with no reported medication related AEs related to SGLT-2 inhibitors)
• -Initiation or discontinuation of prescription or non-prescription weight loss drugs within 8 weeks of screening. Use of prescription or non-prescription weight loss drugs must be stable during the study.
• -Medical History and Concurrent Diseases
• -Pregnant, positive serum pregnancy test, planning to become pregnant during the clinical trials, or breastfeeding
• -History of unstable or rapidly progressive renal disease
• -History of unresolved vesico-ureteral reflux
• -History of or current, acute or chronic pancreatitis
• -History of hemoglobinopathy, with the exception of sickle cell trait or thalassemia minor; or chronic or recurrent hemolysis
• -Malignancy within 5 years of the screening visit (with the exception of treated basal cell or treated squamous cell carcinoma)
• -Replacement or chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid taken for > 4 weeks within 3 months prior to the Day 1 visit
• -Physical and Laboratory Test Findings
• -Abnormal renal function,
• -An abnormal thyroid-stimulating hormone (TSH) value at enrollment will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded.
• -Hematuria (confirmed by microscopy at screening) with no explanation as judged by the Investigator up to randomization.
• -Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2× upper limit of normal (ULN), or clinically significant hepatic disease.
• -Serum total bilirubin (TB) > 2x ULN unless exclusively caused by Gilbert’s syndrome
• -Positive serologic evidence of current infectious liver disease including anti hepatitis A virus (HAV) (IgM), hepatitis B surface antigen (HBsAg), or anti hepatitis C virus (HCV). Patients who have isolated positive anti-hepatitis B surface antibodies may be included.
• -Anemia of any etiology
• -Volume-depleted subjects.
• - Allergies and Adverse Drug Reaction
• -Known allergy, sensitivity or contraindication to any study drug or its excipient/vehicle
• -Other Exclusion Criteria
• -Subject is currently abusing alcohol or other drugs or has done so within the last 6 months prior to the screening visit.
• -Prisoners or subjects who are involuntarily incarcerated. (Note: under certain specific circumstances a person who has been imprisoned may be included or permitted to continue as a subject. Strict conditions apply and Sponsor/designee approval is required.)
• -Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
• -Psychiatric or cognitive disorder that will, in the opinion of investigators, limit the subject’s ability to comply with the study medications and monitoring.
• -Subjects who have contraindications to therapy as outlined in the saxagliptin and dapagliflozin Investigator Brochure or local package inserts.
• -Participation and receiving IP in another clinical study during the prior 3 months