Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin

Effect of Dapagliflozin on 24-hour Blood Glucose in 92 Type 2 Diabetes Patients Inadequately
Controlled With Either Metformin Or Insulin

Inclusion Criteria:

- Type 2 diabetes mellitus (T2DM)

- Treated with either stable dose of metformin alone > or = to 1500mg/day or stable
dose of insulin > or = to 30 units/day and up to 2OAD medications for at least 8
weeks

- Hemoglobin A1c (HbA1c) 7.5% to 10.5% at screening

- Body mass index (BMI) < or = to 45 kg/m2

Exclusion Criteria:

- For patients who enter the study taking a stable dose of metformin, history of taking
OAD medications other than metformin during the 8 weeks prior to screening or have
been on insulin therapy within 1 year of screening

- For patients who enter the study taking insulin, history of taking any other therapy
outside of the stable insulin and up to 2 OAD medications for 8 weeks prior to
screening.

- Use of sulfonylureas during the 8 weeks prior to screening

- Prior exposure to dapagliflozin or any sodium-glucose co-transporter 2 (SGLT-2)
inhibitor

- Ingestion of any medication know to affect glucose metabolism for >7 consecutive days
during the 3 months prior to Screening

- Ingestion of prescription or over the counter weight loss medication during 3 months
prior to screening