Back to resultsA Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Faster-acting insulin aspart
Faster-acting insulin aspart
insulin aspart
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Type 1 diabetes mellitus (diagnosed clinically) for at least 12 months prior to the screening visit (Visit 1)
- Treatment with the same insulin analogue by CSII (continuous subcutaneous insulin infusion) for the previous 3 months prior to the screening visit (Visit 1)
- Using a MiniMed Paradigm® pump (515/715, 522/722 or 523/723) for the previous 6 months prior to the screening visit (Visit 1)
- Glycosylated haemoglobin (HbA1c) below or equal to 9.0% by central laboratory
- Body Mass Index (BMI) below or equal to 35.0 kg/m^2
Exclusion Criteria:
- History of diabetic ketoacidsosis (DKA) episodes requiring hospitalization within 6 months prior to the screening visit (Visit 1)
- History of abscess at the infusion site within 6 months prior to the screening visit (Visit 1)
- Hypoglycaemic unawareness as judged by the Investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to the screening visit (Visit 1)
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Formulation 1
Formulation 2
Insulin aspart (NovoLog®)
Arm Description
Outcomes
Primary Outcome Measures
Mean change in plasma glucose concentration
Secondary Outcome Measures
Self-measured plasma glucose (SMPG) 7-point profile
Self-measured plasma glucose (SMPG) 9-point profile
Number of adverse events (AEs) (including infusion site reactions/infections)
Number of hypoglycaemic episodes
Number of unexplained self-reported episodes of hypoglycaemia or hyperglycaemia (confirmed by SMPG)
Number of episodes of infusion set occlusions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01682902
Brief Title
A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes
Official Title
A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 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 the United States of America (USA). The aim of the trial is to evaluate continuous subcutaneous infusion of NN1218 formulations and NovoLog® in subjects with type 1 diabetes.
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Formulation 1
Arm Type
Experimental
Arm Title
Formulation 2
Arm Type
Experimental
Arm Title
Insulin aspart (NovoLog®)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Faster-acting insulin aspart
Other Intervention Name(s)
NN1218
Intervention Description
Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.
Intervention Type
Drug
Intervention Name(s)
Faster-acting insulin aspart
Other Intervention Name(s)
NN1218
Intervention Description
Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.
Primary Outcome Measure Information:
Title
Mean change in plasma glucose concentration
Time Frame
From 0-2 hours after administration of standardised meal after the first, the second, and the third 14-day treatment period
Secondary Outcome Measure Information:
Title
Self-measured plasma glucose (SMPG) 7-point profile
Time Frame
After the first, the second, and the third 14-day treatment period
Title
Self-measured plasma glucose (SMPG) 9-point profile
Time Frame
After the first, the second, and the third 14-day treatment period
Title
Number of adverse events (AEs) (including infusion site reactions/infections)
Time Frame
Days 0-14 for each treatment periods
Title
Number of hypoglycaemic episodes
Time Frame
Days 0-14 for each treatment period
Title
Number of unexplained self-reported episodes of hypoglycaemia or hyperglycaemia (confirmed by SMPG)
Time Frame
Days 0-14 for each treatment period
Title
Number of episodes of infusion set occlusions
Time Frame
Days 0-14 for each treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 1 diabetes mellitus (diagnosed clinically) for at least 12 months prior to the screening visit (Visit 1)
Treatment with the same insulin analogue by CSII (continuous subcutaneous insulin infusion) for the previous 3 months prior to the screening visit (Visit 1)
Using a MiniMed Paradigm® pump (515/715, 522/722 or 523/723) for the previous 6 months prior to the screening visit (Visit 1)
Glycosylated haemoglobin (HbA1c) below or equal to 9.0% by central laboratory
Body Mass Index (BMI) below or equal to 35.0 kg/m^2
Exclusion Criteria:
History of diabetic ketoacidsosis (DKA) episodes requiring hospitalization within 6 months prior to the screening visit (Visit 1)
History of abscess at the infusion site within 6 months prior to the screening visit (Visit 1)
Hypoglycaemic unawareness as judged by the Investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to the screening visit (Visit 1)
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
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28055230
Citation
Bode BW, Johnson JA, Hyveled L, Tamer SC, Demissie M. Improved Postprandial Glycemic Control with Faster-Acting Insulin Aspart in Patients with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion. Diabetes Technol Ther. 2017 Jan;19(1):25-33. doi: 10.1089/dia.2016.0350. Epub 2017 Jan 5.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes
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