Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes (DEPICT 1)
Type 1 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Dapagliflozin, Efficacy, Safety, Add on to insulin, Oral Antidiabetic, Type 1 diabetes
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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Arm A: Dapagliflozin
Arm B: Dapagliflozin
Arm C: Placebo for Dapagliflozin
Dapagliflozin 5 mg tablet orally, once daily for 52 weeks
Dapagliflozin 10 mg tablet orally, once daily for 52 weeks
Placebo tablet orally, once daily for 52 weeks