Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics

Inclusion Criteria:

- Diagnosis of Type 1 Diabetes mellitus (T1DM)

- Central laboratory C-peptide < 0.7 ng/ml (0.23 nmol/L)

- Insulin use for at least 12 months per patient reported or medical records

- Method of insulin administration (MDI or CSII) must have been unchanged for at least 3
months prior to screening

- Subjects must be on a total insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior
to screening

- If on MDI insulin administration, subject must be on ≥ 3x injections per day

- Screening Visit: Central laboratory HbA1c ≥ 7.7% and ≤ 11.0%

- Body mass index (BMI) ≥ 18.5 kg/m2

Exclusion Criteria:

- History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young
(MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased
beta cell capacity

- Taking metformin and/or thiazolidinediones within 2 months prior to screening

- Taking any antidiabetic medication (other than insulin), within 1 month prior to
screening

- Taking GLP-1 receptor agonist within 2 months prior to screening for once weekly
administration and within 1 month prior to screening for once or twice daily
administration

- History of diabetes ketoacidosis requiring medical intervention within 1 month prior
to screening

- History of hospital admission for glycemic control (either hyperglycemia or
hypoglycemia) within 1 month prior to screening

- Frequent episodes of severe hypoglycemia (more than one episode requiring medical
assistance, emergency care), and/or glucagon therapy administered by a third-party
individual within 1 month prior to screening

- History of Addison's disease