Intervention: Dapagliflozin Propanediol
Trial phase: Phase 4
SMILES: CC(O)CO.CCOc1ccc(Cc2cc(C3OC(CO)C(O)C(O)C3O)ccc2Cl)cc1.O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Dapagliflozin 10 mg + Saxagliptin Placebo

Dapagliflozin 10mg: Dapagliflozin 10mg PO QD
Eligibility criteria:
Inclusion Criteria:

Able to understand the study, and provide a signed & dated informed consent.
Diagnosis of Type 2 diabetes mellitus using criteria of the American Diabetes Association.
30-70 years old.
HbA1C 7 to 10%, both inclusive
BMI of 25 - 39.9 kg/m2 both inclusive.
Taking a stable dose (for 12 weeks) of Metformin (any dosage) and/or Insulin (any dosage) for the treatment of T2DM

Patients with current Cardiovascular Disease (CVD) in tye 2 diabetes patients, defined by ≥ 1 of the following:

MI >2 months prior
Multivessel CAD
Angina (intermittent or chronic)
Single vessel CAD with positive stress test or UA hospitalization in prior year
UA >2 months prior and evidence of CAD
Stroke >2 months prior
Occlusive PAD
Proteinuria of more than 30mg/dl

Exclusion Criteria:

Planned CV surgery or angioplasty in 1 month
Prior surgery with chronic malabsorption (eg, bariatric) in prior 1 year
Diagnosis of Type 1 diabetes mellitus
History of GAD antibody positive status
Uncontrolled Inflammatory Disease/Inflammatory drug use. **Evaluated by PI on case-by-case basis**
Recent history of diabetic keto-acidosis in the past 3months, or recurrent history of diabetic ketoacidosis (≥ 3 times)
Active bladder cancer
Active wounds (e.g. Diabetic ulcers) or recent surgery within 1 month
Untreated hyper/hypothyroidism
Women of child bearing potential who are not willing to use a contraceptive method to avoid pregnancy for the 16 weeks of study duration
Women who are pregnant or breastfeeding
Implanted devices (eg. Pacemaker) that may interact with Tanita scale
Any other clinical condition that would jeopardize patients safety while participating in this clinical trial Concomitant Medications
Taking any other oral anti-diabetic agent other than Metformin and/or Insulin for their treatment of T2DM
Beginning statin medications in the past 1 month or change in statin dose in the past 1 month
Use of consistent long-term steroid medication (oral, inhaled, injected) within the last 1 month
Treatment with a strong cytochrome P450 3A4 (CYP34A) or P-gp inducer (ie. Rifampin)
Subjects with a history of any serious hypersensitivity reaction to Dapagliflozin / Saxagliptin or another SGLT-2 inhibitor/ DPP4 inhibitor Laboratory Findings
Uncontrolled hyperglycemia, defined as a fasting glucose >240 mg/dL (>13.3 mmol/L) at screening.
Liver disease with ALT, AST or ALP x3 ULN
eGFR < 60 mL/min/1.73 m2 by MDRD equation in the past 3 months
Clinically significant RBC disorders such as hemoglobinopathies
Serum creatinine levels ≥1.8 mg/dL with estimated eGFP < 60 mL/min
Triglycerides > 450 mg/dL
Baseline Hematuria (judged by a urinalysis dipstick at screening) Social History
Active smokers
Chronic or persistent alcohol or drug abuse
Prisoners or subjects who are involuntarily incarcerated
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg. infectious disease) illness
Participation in another trial with an investigational drug within 30 days prior to informed consent