Treatment of low blood sugar with glucagon among patients with type 1 diabetes mellitus who have an impaired insulin production.

Phase 1

Conditions: Patients with type 1 diabetes mellitus
MedDRA version: 17.0Level: LLTClassification code 10012608Term: Diabetes mellitus insulin-dependentSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2014-002267-15-DK

Lead Sponsor: Hvidovre Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Males and females aged 18-65 years
-Diagnosed with type 1 diabetes > 3 years
-HbA1c < 58 mmol/mol
-No appearance of autonome neuropathy
-Body mass index (BMI) between 20-25 kg/m2
-Remained hypoglycæmic awareness
-Insulin pump treatment > 1 year
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Allergic to glucagon or lactose
Pregnancy, breast-feeding, intention of becoming pregnant, or not using adequate contraception
Any disease or condition which would interfere with the subject's safety
Use of a medication that significantly impacts glucose metabolism

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of minor doses of glucagon during hypoglycemia among patients with type 1 diabetes. The subject will complete four study days where different doses of glucagon are administered during an insulin induced hypoglycæmi. The effect on glucose metabolism is investigated. ;Secondary Objective: Not applicable;Primary end point(s): Primary: Glucagon dose related elevation of plasma glucose<br>;Timepoint(s) of evaluation of this end point: The evaluation is performed during the four study days.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary: Duration of hyperglycemic effect of glukagon<br>Tertiary: Glucagon influence on other glucose homeostatic substances, i.e. Catecolamines, cortisol, growth hormone, ketone bodies, FFA/TG, endogenous glucagon;Timepoint(s) of evaluation of this end point: The evalution is performed at the end of the study.