Back to resultsComparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
insulin degludec
insulin degludec/insulin aspart 30
insulin degludec/insulin aspart 40
insulin degludec/insulin aspart 45
insulin degludec/insulin aspart 55
insulin aspart
biphasic insulin aspart 30
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results
- Diagnosed with type 1 diabetes and treated with insulin for above or equal to 12 months
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
Exclusion Criteria:
- A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trialproduct, as judged by the Investigator
- A subject who is known to have hepatitis or who is carrier of the Hepatitis B surface antibodies, or has a positive result to the test for HIV antigen (HBsAg) or Hepatitis C antibodies
- A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
IDegAsp 30 + placebo
Insulin aspart + insulin degludec - low concentration 1
IDegAsp 40 + placebo
Insulin aspart + insulin degludec - high concentration 1
IDegAsp 45 + placebo
Insulin aspart + insulin degludec
IDegAsp 55 + placebo
Insulin aspart + insulin degludec - high concentration
BIAsp 30 + placebo
Arm Description
Outcomes
Primary Outcome Measures
Area under the insulin aspart concentration curve
Secondary Outcome Measures
Area under the glucose infusion rate curve
Area under the serum insulin 454 concentration curve
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01868568
Brief Title
Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes
Official Title
A Randomised, Double-blind, Multiple Period Cross-over Trial Comparing Insulin 454 and Insulin Aspart Fixed Combination Products With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared to Biphasic Insulin Aspart 30 (NovoMix® 30) in Subjects With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (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 this trial is to compare insulin degludec and insulin aspart (IDegAsp) co-formulations with separately injected, simultaneous doses of insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30 (NovoMix® 30) in subjects with type 1 diabetes mellitus. Each subject will be randomised to four out of nine possible treatment arms. IDegAsp 40, IDegAsp 45, IDegAsp 55 and IDeg high concentration were explorative formulations, not similar to the proposed commercial formulation.
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
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IDegAsp 30 + placebo
Arm Type
Experimental
Arm Title
Insulin aspart + insulin degludec - low concentration 1
Arm Type
Experimental
Arm Title
IDegAsp 40 + placebo
Arm Type
Experimental
Arm Title
Insulin aspart + insulin degludec - high concentration 1
Arm Type
Experimental
Arm Title
IDegAsp 45 + placebo
Arm Type
Experimental
Arm Title
Insulin aspart + insulin degludec
Arm Type
Experimental
Arm Title
IDegAsp 55 + placebo
Arm Type
Experimental
Arm Title
Insulin aspart + insulin degludec - high concentration
Arm Type
Experimental
Arm Title
BIAsp 30 + placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Administered subcutaneously (s.c., under the skin).
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart 30
Intervention Description
A single dose administered subcutaneously (s.c., under the skin).
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart 40
Intervention Description
A single dose administered subcutaneously (s.c., under the skin).
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart 45
Intervention Description
A single dose administered subcutaneously (s.c., under the skin).
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart 55
Intervention Description
A single dose administered subcutaneously (s.c., under the skin).
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
A single dose administered subcutaneously (s.c., under the skin).
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 30
Intervention Description
A single dose administered subcutaneously (s.c., under the skin).
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
A single dose administered subcutaneously (s.c., under the skin).
Primary Outcome Measure Information:
Title
Area under the insulin aspart concentration curve
Time Frame
0-2 hours after dosing
Secondary Outcome Measure Information:
Title
Area under the glucose infusion rate curve
Time Frame
0-26 hours after dosing
Title
Area under the serum insulin 454 concentration curve
Time Frame
0-120 hours after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results
Diagnosed with type 1 diabetes and treated with insulin for above or equal to 12 months
Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
Exclusion Criteria:
A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trialproduct, as judged by the Investigator
A subject who is known to have hepatitis or who is carrier of the Hepatitis B surface antibodies, or has a positive result to the test for HIV antigen (HBsAg) or Hepatitis C antibodies
A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing
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:
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes
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