Treatment of Low Blood Sugar With Glucagon Among Patients With Type 1 Diabetes

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

DRUG

Glucagon

Glucagon is given in three different doses according to three research days.

OTHER

Isotonic saline solution

Placebo

Sponsors & Collaborators

• The Novo Nordic Foundation

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• Hvidovre University Hospital

  lead OTHER

Principal Investigators

• Ajenthen Ranjan, MD · Hvidovre University Hospital

• Signe Schmidt, MD, PhD · Hvidovre University Hospital

• Kirsten Nørgaard, MD, DMSc · Hvidovre University Hospital

• Sten Madsbad, Prof, DMSc · Hvidovre University Hospital

• Jens J Holst, Prof, DMSc · University of Copenhagen

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2015-01-31

Completion

2015-07-31

Countries

• Denmark

Study Locations