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