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

A Trial Comparing the Effect of Exercise on Blood Glucose Between Insulin Degludec and Insulin Glargine in Subjects With Type 1 Diabetes

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01704417

Enrollment

Registered

2012-10-11

Start date

2012-10-31

Completion date

2013-03-31

Last updated

2016-12-16

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

Conditions

Diabetes, Diabetes Mellitus, Type 1

Brief summary

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).

Interventions

DRUGinsulin degludec

Subjects will be randomised to a treatment sequence consisting of two treatment periods in which the subjects will receive IDeg and IGlar, respectively. Administered subcutaneously (s.c., under the skin) once daily. Dose individually adjusted.

DRUGinsulin glargine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
BGpre-exe - BGminimum,exe, difference between blood glucose concentration before exercise and the minimum blood glucose concentration observed during exercise	From 0 to 30 minutes

Secondary

Measure	Time frame
BGmean,exe, mean blood glucose concentration during exercise	From 0 to 30 minutes
BGmean,30-180min,post-exe, mean blood glucose concentration	Between 30 and 180 minutes, i.e. post-exercise
BGminimum,30-180min,post-exe, minimum blood glucose concentration	Between 30 and 180 minutes, i.e. post-exercise

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026