Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

• Status: Completed
• Trial end date: 2017-08-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Bristol-Myers Squibb
• Treatments: Dapagliflozin

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