Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Launched by ASTRAZENECA · Oct 15, 2014
Trial Information
Current as of June 21, 2025
Completed
Keywords
ClinConnect Summary
Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics
Gender
ALL
Eligibility criteria
- 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
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Minneapolis, Minnesota, United States
A Coruña, , Spain
Aurora, Colorado, United States
Little Rock, Arkansas, United States
Milano, , Italy
Barcelona, , Spain
Las Vegas, Nevada, United States
Albany, New York, United States
Leuven, , Belgium
Jerusalem, , Israel
Siena, , Italy
Denver, Colorado, United States
Dundee, , United Kingdom
Miami, Florida, United States
Salt Lake City, Utah, United States
Valencia, , Spain
Innsbruck, , Austria
Esbjerg, , Denmark
Tampere, , Finland
Haifa, , Israel
Des Moines, Iowa, United States
Jacksonville, Florida, United States
Asheville, North Carolina, United States
Dallas, Texas, United States
Bonheiden, , Belgium
Odense, , Denmark
Witten, , Germany
Zalaegerszeg, , Hungary
Safed, , Israel
Belfast, , United Kingdom
Aguascalientes, , Mexico
Langhorne, Pennsylvania, United States
Nashville, Tennessee, United States
Karlstad, , Sweden
Nottingham, , United Kingdom
Kingsport, Tennessee, United States
Houston, Texas, United States
Lund, , Sweden
London, Ontario, Canada
Laval, Quebec, Canada
Greenville, North Carolina, United States
Concord, , Australia
Torreon, , Mexico
Amarillo, Texas, United States
Buffalo, New York, United States
Chesterfield, Missouri, United States
Fitzroy, , Australia
Timisoara, , Romania
Balatonfured, , Hungary
San Diego, California, United States
Ravenna, , Italy
Liege, , Belgium
Sevilla, , Spain
Baja, , Hungary
Firenze, , Italy
Morehead City, North Carolina, United States
Torrance, California, United States
Kalamazoo, Michigan, United States
Dijon, , France
La Mesa, California, United States
Heidelberg West, , Australia
Winnipeg, Manitoba, Canada
Aschaffenburg, , Germany
Bad Oeynhausen, , Germany
Budapest, , Hungary
Sesto San Giovanni, , Italy
Mexico, , Mexico
Sheffield, , United Kingdom
Encino, California, United States
Louisville, Kentucky, United States
Portland, Maine, United States
Tarzana, California, United States
Wien, , Austria
Hyattsville, Maryland, United States
Olympia, Washington, United States
Port Orange, Florida, United States
Wollongong, , Australia
Guadalajara, , Mexico
Zapopan, Jalisco, , Mexico
Zapopan, , Mexico
Iasi, , Romania
Göteborg, , Sweden
Kuopio, , Finland
Oulu, , Finland
Chesterfield, , United Kingdom
Welwyn Garden City, , United Kingdom
Saint Herblain Cedex, , France
Palermo, , Italy
Cooper City, Florida, United States
Saint Stefan/Stainz, , Austria
Neuwied, , Germany
Monterrey, , Mexico
Uppsala, , Sweden
Schweinfurt, , Germany
Southport, , Australia
Létavértes, , Hungary
Chihuahua, , Mexico
Rockville, Maryland, United States
Bucuresti, , Romania
Oldenburg, , Germany
Idaho Falls, Idaho, United States
Chapel Hill, North Carolina, United States
Daw Park, , Australia
Newcastle, , Australia
Vancouver, British Columbia, Canada
Arhus C, , Denmark
Randers Nø, , Denmark
Helsinki, , Finland
Jyvaskyla, , Finland
Besançon Cedex, , France
Corbeil Essonnes, , France
Vandoeuvre Les Nancy, , France
Aßlar, , Germany
Falkensee, , Germany
Munich, , Germany
Munster, , Germany
Pohlheim, , Germany
Sulzbach, , Germany
Szeged, , Hungary
Tel Aviv, , Israel
Tikva, , Israel
Padowa, , Italy
Cuernavaca, , Mexico
Merida, , Mexico
Dolj, , Romania
Galati, , Romania
Almeria, , Spain
Patients applied
Trial Officials
Anna Maria Langkilde
Study Director
AstraZeneca
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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