Phase 1 Study to Explore the Safety and Pharmacokinetics of DAPAglifozin in Adolescents and Adults With Type 1 Diabetes

Sponsor
Kinderkrankenhaus auf der Bult
Study ID
NCT02325206
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • dapagliflozin — DRUG
    one administration in the morning
  • Placebo — DRUG
    one administration in the morning

Study Details

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

Key Dates

Start date
Dec 31, 2014
Status verified
Feb 2016
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: dapafliflozin
    one administration of 10mg dapagliflozin as tablet
  • Placebo Comparator: placebo
    one administration as tablet identical to the experimental drug

Primary Outcome Measure

reduction of intravenous insulin dose [ Time Frame: 24hours ]

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