Back to resultsComparison of Insulin Degludec With Insulin Glargine in Subjects With Type 1 Diabetes Mellitus
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) and treated with insulin for at least 12 months
- Subject is considered to be generally healthy, except for the underlying diabetes mellitus and related morbidity (such as well controlled hypertension and dyslipidaemia) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- Body Mass Index (BMI) between 18.0 and 28.0 kg/m^2 (both inclusive)
- Glycosylated haemoglobin (HbA1c) below or equal to 10.0 % based on central laboratory results
- Subject with a daily basal insulin requirement of between 0.2 IU/kg/day and 0.6 IU/kg/day will be allowed to participate in the trial. Current total daily treatment with insulin must be less than 1.2 U/kg/day
Exclusion Criteria:
- Known or suspected allergy to trial product(s) or related products
- Subject who has participated in any other trials involving investigational products within 3 months preceding the start of dosing
- Subject who has donated any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Low dose
Medium dose
High dose
Arm Description
Outcomes
Primary Outcome Measures
Area under the glucose infusion rate curve
Secondary Outcome Measures
Area under the serum insulin concentration curve at steady state
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01868529
Brief Title
Comparison of Insulin Degludec With Insulin Glargine in Subjects With Type 1 Diabetes Mellitus
Official Title
A Randomised, Single Centre, Double-blind, Two-Period Cross-over, Multiple Dose Trial Comparing the Pharmacodynamic Response of Insulin 454 With Insulin Glargine at Steady-State Conditions in Subjects With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 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 was conducted in Europe. The aim of this trial was to compare the pharmacodynamic (the effect of the investigated drug on the body) response of insulin degludec (insulin 454) with insulin glargine at steady-state conditions in subjects with type 1 diabetes mellitus.
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
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose
Arm Type
Experimental
Arm Title
Medium dose
Arm Type
Experimental
Arm Title
High dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.
Primary Outcome Measure Information:
Title
Area under the glucose infusion rate curve
Time Frame
0-24 hours in steady-state
Secondary Outcome Measure Information:
Title
Area under the serum insulin concentration curve at steady state
Time Frame
0-24 hours after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 1 diabetes mellitus (as diagnosed clinically) and treated with insulin for at least 12 months
Subject is considered to be generally healthy, except for the underlying diabetes mellitus and related morbidity (such as well controlled hypertension and dyslipidaemia) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
Body Mass Index (BMI) between 18.0 and 28.0 kg/m^2 (both inclusive)
Glycosylated haemoglobin (HbA1c) below or equal to 10.0 % based on central laboratory results
Subject with a daily basal insulin requirement of between 0.2 IU/kg/day and 0.6 IU/kg/day will be allowed to participate in the trial. Current total daily treatment with insulin must be less than 1.2 U/kg/day
Exclusion Criteria:
Known or suspected allergy to trial product(s) or related products
Subject who has participated in any other trials involving investigational products within 3 months preceding the start of dosing
Subject who has donated any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening
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 Insulin Degludec With Insulin Glargine in Subjects With Type 1 Diabetes Mellitus
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