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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Dapagliflozin; Insulin; Insulin, Globin Zinc; Metformin

Criteria

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 2 OAD 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