The impact of a glucagon injection before, during and after exercise. A study in patients with type 1 diabetes mellitus

Phase 1

• Conditions: Patients with type 1 diabetes mellitus; MedDRA version: 19.0Level: LLTClassification code 10012608Term: Diabetes mellitus insulin-dependentSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2016-002127-28-DK
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-31
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age 18 - 70 years
- T1D = 2 year
- BMI 20-30 kg/m2
- Insulin pump = 1 year.
- HbA1c < 69 mmol/mol (8.5 %)
- Hypoglycemia awareness (reported by Gold et al.)
- Use of carbohydrate counting and the insulin pump bolus calculator for all meals
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 14
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Allergy or intolerance to lactose or GlucaGen® (Novo Nordisk, Bagsværd, DK)
- Impaired renal function (eGFR < 60 ml/min/1.73m2)
- Liver disease with ALAT > 2.5 times the upper limit of the reference interval
- Use of anti-diabetic medicine (other than insulin), per oral corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
- Known or suspected alcohol or drug abuse
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
- Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- Inability to understand the patient information and to give informed consent
- Physical or mental incapacity to perform exercise
-People with vigorous intensity aerobic physical activity such as swimming, jogging, aerobics, football, tennis, gym, workout etc, more than 3 hours or more per week.
- Chronic use or unable to stop acetaminophen (paracetamol) use
-Allergy to the patch of CGM sensors

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified