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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: insulin degludec; Drug: insulin glargine

• Registration Number: NCT01704417
• Lead Sponsor: Novo Nordisk A/S

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-08
• Study First Submitted QC: 2012-10-08
• Study First Posted: 2012-10-11
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IDeg followed by IGlar	insulin degludec	-
IDeg followed by IGlar	insulin glargine	-
IGlar followed by IDeg	insulin degludec	-
IGlar followed by IDeg	insulin glargine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany