Back to resultsSafety, Tolerability, Pharmacokinetics and Pharmacodynamics of Explorative Formulation of Insulin Degludec
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
insulin degludec
placebo
insulin degludec
isophane human insulin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- HEALTHY SUBJECTS:
- Subjects will be healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- Body mass index (BMI) between 18.0-27.0 kg/m^2 (both inclusive)
- SUBJECTS WITH TYPE 1 AND TYPE 2 DIABETES:
- Subjects will be male volunteers, who 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 or diagnosed with type 2 diabetes mellitus for at least 12 months
- Body Mass Index (BMI) between 18.0-27.0 kg/m^2 (both inclusive) for subjects with type 1 diabetes or 25.0-35.0 kg/m^2 (both inclusive) for subjects with type 2 diabetes
- Glycogylated haemoglobin (HbA1c) maximum 8.5 % based on central laboratory results
- Subjects with type 2 diabetes must have been treated with insulin for the past 3 months prior to screening
Exclusion Criteria:
- Participation in any other trials involving investigational products within 3 months preceding the start of dosing
- History of significant multiple drug allergies or with a known allergy to the trial product or any medicine chemically related to the trial product, as judged by the investigator
- Hepatitis or carrier of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies or a positive result to the test for human immunodeficiency (HIV) antibodies
- Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the investigator
- Subjects who have donated any blood or plasma in the past month or in excess of 1000 ml within the 12 weeks preceding screening
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Trial part 1
Trial part 2
Arm Description
Outcomes
Primary Outcome Measures
Frequency of adverse events (trial part 1 only)
Area under the glucose infusion rate curve (trial part 2 only)
Secondary Outcome Measures
Area under the serum insulin concentration curve
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01865279
Brief Title
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Explorative Formulation of Insulin Degludec
Official Title
A Randomised, Double-blind, Placebo-controlled Single Dose, Dose Escalation Trial With Insulin 454 in Healthy Male Subjects, Followed by a Two-period Cross-over Trial With Insulin 454 and Insulatard® in Male Subjects With Type 1 and Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (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 safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commerical 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, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trial part 1
Arm Type
Experimental
Arm Title
Trial part 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Ascending single doses - 5 dose levels. Escalation to next dose level will be performed following evaluation of safety data.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Ascending single doses - 5 dose levels
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
A single dose corresponding to that of isophane human insulin
Intervention Type
Drug
Intervention Name(s)
isophane human insulin
Intervention Description
A single dose of 0.4 IU/kg is administered to subjects with type 1 diabetes while a single dose of 0.6 IU/kg is administered to subjects with type 2 diabetes
Primary Outcome Measure Information:
Title
Frequency of adverse events (trial part 1 only)
Time Frame
From day prior to dosing and until 10-14 days after dosing
Title
Area under the glucose infusion rate curve (trial part 2 only)
Time Frame
0-24 hours after dosing
Secondary Outcome Measure Information:
Title
Area under the serum insulin concentration curve
Time Frame
0-72 hours after dosing
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
HEALTHY SUBJECTS:
Subjects will be healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
Body mass index (BMI) between 18.0-27.0 kg/m^2 (both inclusive)
SUBJECTS WITH TYPE 1 AND TYPE 2 DIABETES:
Subjects will be male volunteers, who 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 or diagnosed with type 2 diabetes mellitus for at least 12 months
Body Mass Index (BMI) between 18.0-27.0 kg/m^2 (both inclusive) for subjects with type 1 diabetes or 25.0-35.0 kg/m^2 (both inclusive) for subjects with type 2 diabetes
Glycogylated haemoglobin (HbA1c) maximum 8.5 % based on central laboratory results
Subjects with type 2 diabetes must have been treated with insulin for the past 3 months prior to screening
Exclusion Criteria:
Participation in any other trials involving investigational products within 3 months preceding the start of dosing
History of significant multiple drug allergies or with a known allergy to the trial product or any medicine chemically related to the trial product, as judged by the investigator
Hepatitis or carrier of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies or a positive result to the test for human immunodeficiency (HIV) antibodies
Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the investigator
Subjects who have donated any blood or plasma in the past month or in excess of 1000 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
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Explorative Formulation of Insulin Degludec
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