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

Completed · Phase 4 · Has a placebo group

Conditions studied: Type II Diabetes

In brief

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

Key facts

Study ID

NCT02429258

Run by

AstraZeneca

People needed

226

Starts

2015-05-01

Expected to finish

2015-10-01

Last updated by the study team

2017-06-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Huntington Park, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Diego, California, United States
• Research Site — West Hills, California, United States
• Research Site — Cooper City, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Evanston, Illinois, United States
• Research Site — Oxon Hill, Maryland, United States
• Research Site — Henderson, Nebraska, United States
• Research Site — Brooklyn, New York, United States
• Research Site — Rochester, New York, United States
• Research Site — Greensboro, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Dublin, Ohio, United States
• Research Site — Franklin, Ohio, United States
• Research Site — Eugene, Oregon, United States
• Research Site — Lansdale, Pennsylvania, United States
• Research Site — Spartanburg, South Carolina, United States
• Research Site — Bartlett, Tennessee, United States
• Research Site — Dallas, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Hurst, Texas, United States

Full record on ClinicalTrials.gov

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