Treatment of Low Blood Sugar With Glucagon Among Patients With Type 1 Diabetes
Status:
Unknown status
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
Summary
Background: Patients with type 1 diabetes (T1D) need a lifelong supply of external insulin
and are advised to aim for near-normalization of blood glucose levels through intensive
insulin therapy. We propose a new approach for achieving treatment goals in T1D: the combined
use of insulin and glucagon, i.e. dual-hormone treatment.Only recently the prospect of
treating patients with soluble glucagon has arisen and thus studies of low dose glucagon
treatment of mild hypoglycemia are needed to determine whether there is clinical rationale
for dual-hormone treatment of T1D.
Aim: The purpose of this clinical study is to investigate the glycemic response to
subcutaneous glucagon administration during mild hypoglycemia in T1D patients treated with
insulin pump. Different glucagon doses are applied to determine the most appropriate dose for
future dual-hormone treatment of T1D.
Methods: A clinical, randomized, single blinded, crossover study will be conducted. Eight T1D
patients treated with insulin pump are studied on four days. All patients are in good
metabolic control (HbA1c < 7.5%), C-peptide negative and with hypoglycemia awareness. On each
study day, hypoglycemia is induced with subcutaneously insulin and afterward treated with a
single subcutaneous dose of glucagon. The study procedures are identical on all days except
from the administered dose of glucagon (day 1: placebo, day 2: 100 ug, day 3: 200 ug, day 4:
300 ug). All patients are blinded for the glucagon dose and carry out the four days in random
order.
Endpoints: The present study focuses primarily on the dose related plasma glucose response of
glucagon; secondary on the duration of the hyperglycemic effect of glucagon and tertiary the
glucagon effect on catecholamine, cortisol, growth hormone, free fatty acids and
triglycerides.
The study will be conducted from august 2014.
Phase:
Phase 4
Details
Lead Sponsor:
Hvidovre University Hospital
Collaborators:
The Novo Nordic Foundation University of Copenhagen