Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
With
Bristol-Myers Squibb
Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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 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
Clareo Health | Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
