Investigation of Pharmacodynamic Characteristics of Explorative Formulation of Insulin Degludec in Male 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
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Male and are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
- Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results
Exclusion Criteria:
- History of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator
- Participation in any other trials involving investigational products within 3 months preceding the start of dosing
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Part 1 (Once-daily dosing regimen, high concentration)
Part 2 (Twice-daily dosing regimen, high concentration)
Part 3 (Once-daily dosing regimen, low concentration)
Arm Description
Outcomes
Primary Outcome Measures
Area under the glucose infusion rate curve
Secondary Outcome Measures
Maximum glucose infusion rate (GIRmax)
Time to maximum glucose infusion rate (tGIRmax)
Area under the serum insulin degludec curve
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01865318
Brief Title
Investigation of Pharmacodynamic Characteristics of Explorative Formulation of Insulin Degludec in Male Subjects With Type 1 Diabetes
Official Title
A Single Centre, Open-Label, Multiple Dose Trial Examining the Pharmacodynamic Characteristics of Insulin 454 Under Single-Dose and Steady-State Conditions in Male Subjects With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (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 investigate the pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, under single-dose and steady-state conditions in male 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
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1 (Once-daily dosing regimen, high concentration)
Arm Type
Experimental
Arm Title
Part 2 (Twice-daily dosing regimen, high concentration)
Arm Type
Experimental
Arm Title
Part 3 (Once-daily dosing regimen, low concentration)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Administered subcutaneously (s.c., under the skin)
Primary Outcome Measure Information:
Title
Area under the glucose infusion rate curve
Time Frame
0-24 hours after dosing
Secondary Outcome Measure Information:
Title
Maximum glucose infusion rate (GIRmax)
Time Frame
0-24 hours after dosing
Title
Time to maximum glucose infusion rate (tGIRmax)
Time Frame
0-24 hours after dosing
Title
Area under the serum insulin degludec curve
Time Frame
0-96 hours after dosing
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months
Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results
Exclusion Criteria:
History of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator
Participation in any other trials involving investigational products within 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
Investigation of Pharmacodynamic Characteristics of Explorative Formulation of Insulin Degludec in Male Subjects With Type 1 Diabetes
We'll reach out to this number within 24 hrs