A Trial Comparing the Effect of Exercise on Blood Glucose in Subjects With Type 1 Diabetes, Who Are Treated With Either Insulin Degludec or Insulin Glargine

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 1

Diabetes

Treatments

Drug: insulin degludec

Drug: insulin glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01704417

2012-000329-37 (EudraCT Number)

U1111-1127-3402 (Other Identifier)

NN1250-3999

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to compare the effect of exercise on blood glucose in subjects with type 1 diabetes, who are treated with either insulin degludec (IDeg) or insulin glargine (IGlar).

Enrollment

40 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
Body mass index 18.0-27.0 kg/m^2 (both inclusive)
Subjects performing regular physical cardiorespiratory activity
Glycosylated haemoglobin (HbA1c) below or equal to 9.5 %

Exclusion criteria

Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
Supine blood pressure at screening (after resting for at least 5 minutes) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic