Back to resultsA 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
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
insulin degludec
insulin glargine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
IDeg followed by IGlar
IGlar followed by IDeg
Arm Description
Outcomes
Primary Outcome Measures
BGpre-exe - BGminimum,exe, difference between blood glucose concentration before exercise and the minimum blood glucose concentration observed during exercise
Secondary Outcome Measures
BGmean,exe, mean blood glucose concentration during exercise
BGmean,30-180min,post-exe, mean blood glucose concentration
BGminimum,30-180min,post-exe, minimum blood glucose concentration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01704417
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IDeg followed by IGlar
Arm Type
Experimental
Arm Title
IGlar followed by IDeg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
BGmean,exe, mean blood glucose concentration during exercise
Time Frame
From 0 to 30 minutes
Title
BGmean,30-180min,post-exe, mean blood glucose concentration
Time Frame
Between 30 and 180 minutes, i.e. post-exercise
Title
BGminimum,30-180min,post-exe, minimum blood glucose concentration
Time Frame
Between 30 and 180 minutes, i.e. post-exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26450456
Citation
Heise T, Bain SC, Bracken RM, Zijlstra E, Nosek L, Stender-Petersen K, Rabol R, Rowe E, Haahr HL. Similar risk of exercise-related hypoglycaemia for insulin degludec to that for insulin glargine in patients with type 1 diabetes: a randomized cross-over trial. Diabetes Obes Metab. 2016 Feb;18(2):196-9. doi: 10.1111/dom.12588. Epub 2015 Nov 27.
Results Reference
result
PubMed Identifier
33315813
Citation
McCarthy O, Pitt J, Wellman B, Eckstein ML, Moser O, Bain SC, Bracken RM. Blood Glucose Responses during Cardiopulmonary Incremental Exercise Testing in Type 1 Diabetes: A Pooled Analysis. Med Sci Sports Exerc. 2021 Jun 1;53(6):1142-1150. doi: 10.1249/MSS.0000000000002584.
Results Reference
derived
PubMed Identifier
33184152
Citation
Eckstein ML, Farinha JB, McCarthy O, West DJ, Yardley JE, Bally L, Zueger T, Stettler C, Boff W, Reischak-Oliveira A, Riddell MC, Zaharieva DP, Pieber TR, Muller A, Birnbaumer P, Aziz F, Brugnara L, Haahr H, Zijlstra E, Heise T, Sourij H, Roden M, Hofmann P, Bracken RM, Pesta D, Moser O. Differences in Physiological Responses to Cardiopulmonary Exercise Testing in Adults With and Without Type 1 Diabetes: A Pooled Analysis. Diabetes Care. 2021 Jan;44(1):240-247. doi: 10.2337/dc20-1496. Epub 2020 Nov 12.
Results Reference
derived
PubMed Identifier
29201153
Citation
Moser O, Eckstein ML, McCarthy O, Deere R, Bain SC, Haahr HL, Zijlstra E, Bracken RM. Poor glycaemic control is associated with reduced exercise performance and oxygen economy during cardio-pulmonary exercise testing in people with type 1 diabetes. Diabetol Metab Syndr. 2017 Nov 21;9:93. doi: 10.1186/s13098-017-0294-1. eCollection 2017.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
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
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