Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 1 Diabetes Mellitus

In brief

The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

Key facts

Study ID

NCT02460978

Run by

AstraZeneca

People needed

815

Starts

2015-07-08

Expected to finish

2018-04-18

Last updated by the study team

2019-03-05

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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 any non-insulin antihyperglicemic agent 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
• Taking metformin and/or thiazolidinediones within 2 months prior to screening
• 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

Where it is running

• Research Site — Fresno, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Orange, California, United States
• Research Site — San Mateo, California, United States
• Research Site — San Ramon, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — Golden, Colorado, United States
• Research Site — Newark, Delaware, United States
• Research Site — Bradenton, Florida, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Fort Lauderdale, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami Springs, Florida, United States
• Research Site — St. Petersburg, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Roswell, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Des Moines, Iowa, United States
• Research Site — Overland Park, Kansas, United States
• Research Site — Lexington, Kentucky, United States
• Research Site — Concord, California, United States

Full record on ClinicalTrials.gov

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