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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01704417

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 1	Drug: insulin degludec Drug: insulin glargine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IDeg followed by IGlar	Drug: insulin 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. Drug: insulin glargine 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.
Experimental: IGlar followed by IDeg	Drug: insulin 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. Drug: insulin glargine 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.

Arm

Intervention/Treatment

Experimental: IDeg followed by IGlar

Drug: insulin 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.

Drug: insulin glargine

Experimental: IGlar followed by IDeg

Drug: insulin degludec

Drug: insulin glargine

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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