BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes

Study Classification : Safety, Pharmacokinetics and Pharmacodynamics

Inclusion Criteria:

- Type 1 diabetes with central lab Glycosylated hemoglobin (A1C) ≥ 7.0% and ≤ 10.0%

- Insulin use for at least 12 months and initiation immediately after diagnosis of
diabetes

- Method of Insulin administration [multiple daily injections (MDI) or continuous
subcutaneous Insulin infusion (CSII)] stable ≥ 3 months

- Stable basal Insulin dose ≥ 2 weeks

- Ages 18 to 65 years

- Central laboratory C-peptide value of < 0.7 ng/mL

- Body mass index (BMI) 18.5 to 35.0 kg/m2

Exclusion Criteria:

- History of type 2 diabetes mellitus (T2DM), maturity onset diabetes of young (MODY),
pancreatic surgery or chronic pancreatitis

- Oral hypoglycemic agents

- History of diabetes ketoacidosis (DKA) within 24 weeks

- History of hospital admission for glycemic control within 6 months

- Frequent episodes of hypoglycemia (2 unexplained within 3 months) or hypoglycemic
unawareness

- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) or Serum total
bilirubin > 2X Upper limit of normal (ULN)

- Abnormal Free T4 [if screening Thyroid Stimulating Hormone (TSH) abnormal]

- Estimated glomerular filtration rate (eGFR) Modification of Diet in Renal Disease
(MDRD) formula ≤ 60 mL/min/1.73m2

- Cardiovascular (CV)/Vascular Diseases within 6 months