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

Treatment of hypoglycemia with glucagon among patients with type 1 diabetes mellitus - GluST1

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002267-15-DK

Enrollment

Unknown

Registered

2014-06-26

Start date

2014-07-31

Completion date

Unknown

Last updated

2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with type 1 diabetes mellitus MedDRA version: 17.0 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent System Organ Class: 100000004861

Interventions

Trade Name: Glucagen(r) Product Name: GlucaGen Product Code: SUB02347MIG Pharmaceutical Form: Powder and solution for solution for injection INN or Proposed INN: GLUCAGON CAS Number: 16941-32-5 Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Males and females aged 18-65 years - Diagnosed with type 1 diabetes > 3 years - HbA1c 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

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

Design outcomes

Primary

Measure	Time frame
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 ;Timepoint(s) of evaluation of this end point: The evaluation is performed during the four study days.	—

Measure

Time frame

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 ;Timepoint(s) of evaluation of this end point: The evaluation is performed during the four study days.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary: Duration of hyperglycemic effect of glukagon 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.	—

Countries

Denmark

Contacts

Public ContactAjenthen Ranjan

Hvidovre Hospital

ajenthen.ranjan.02@regionh.dk004526 19 66 04

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026