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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01704417
First received: October 8, 2012
Last updated: August 9, 2013
Last verified: August 2013

October 8, 2012
August 9, 2013
October 2012
March 2013   (final data collection date for primary outcome measure)
BGpre-exe - BGminimum,exe, difference between blood glucose concentration before exercise and the minimum blood glucose concentration observed during exercise [ Time Frame: From 0 to 30 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01704417 on ClinicalTrials.gov Archive Site
  • BGmean,exe, mean blood glucose concentration during exercise [ Time Frame: From 0 to 30 minutes ] [ Designated as safety issue: No ]
  • BGmean,30-180min,post-exe, mean blood glucose concentration [ Time Frame: Between 30 and 180 minutes, i.e. post-exercise ] [ Designated as safety issue: No ]
  • BGminimum,30-180min,post-exe, minimum blood glucose concentration [ Time Frame: Between 30 and 180 minutes, i.e. post-exercise ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • 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: IDeg followed by IGlar
    Interventions:
    • Drug: insulin degludec
    • Drug: insulin glargine
  • Experimental: IGlar followed by IDeg
    Interventions:
    • Drug: insulin degludec
    • Drug: insulin glargine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01704417
NN1250-3999, 2012-000329-37, U1111-1127-3402
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Carsten Roepstorff Novo Nordisk A/S
Novo Nordisk A/S
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP