Phase 1 Study to Explore the Safety and Pharmacokinetics of DAPAglifozin in Adolescents and Adults With Type 1 Diabetes
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
Dapagliflozin has been effective at lowering glucose and hemoglobin A1c (HbA1C) in subjects
with tpye 2 diabetes (T2DM), when studied as monotherapy as well as in combination with
insulin or oral anti-diabetic medications.This lead to investigations if this therapy would
also be of benefit in type 1 diabetes as intensive insulin therapy is associated with glucose
fluctuations, hypoglycemia, weight gain, and subsequent insulin resistance, all of which may
reduce efficacy.
The purpose of the pilot study is to collect clinical data on the HbA1c-dependent effect of a
single-dose of 10mg dapagliflozin on the insulin dose administered intravenously during a
glucose-infusion and an oral mixed-meal for the ensuing 24 hours with blood glucose kept
between 160 - 220 mg/dl.
The first objective is to investigate the degree of insulin dose reduction 24 hours after a
single dose of 10mg dapagliflozin in patients with type 1 diabetes Further objectives are to
investigate
- the effect on urinary glucose excretion
- if this effect is influenced by baseline glycemic control
- if dapagliflozin influences postprandial insulin need
- if dapagliflozin is associated with elevated ß-hydroxybutyrate levels
- PK after oral administration of 10mg dapagliflozin