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Comparison of Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
insulin degludec/insulin aspart 30
insulin degludec/insulin aspart 40
insulin degludec/insulin aspart 50
insulin degludec
insulin aspart
biphasic insulin aspart 30
insulin degludec/insulin aspart 40
insulin degludec/insulin aspart 50
biphasic insulin aspart 30
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • The subject will be a male volunteer, who is considered to be generally healthy, except for underlying diabetes mellitus and concomitant medical complications (e.g. hypertension) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
  • Glycosylated haemoglobin A1c (HbA1c) below or equal to 10 % based on central laboratory results
  • ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 1 DIABETES:
  • 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)
  • ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 2 DIABETES:
  • Diagnosed with type 2 diabetes mellitus for at least 12 months
  • Treated with insulin for the last 3 months prior to screening.
  • Body Mass Index (BMI) between 22.0 and 35.0 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 trial product, as judged by the Investigator
  • 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 Type

Experimental

Experimental

Arm Label

Trial part 1

Trial part 2

Arm Description

Outcomes

Primary Outcome Measures

Area under the insulin aspart concentration curve from 0-2 hours (for subjects with type 1 diabetes)
Maximum glucose infusion rate divided by the average glucose infusion rate (for subjects with type 2 diabetes)

Secondary Outcome Measures

Area under the glucose infusion rate curve
Area under the serum insulin degludec concentration curve

Full Information

First Posted
May 27, 2013
Last Updated
October 22, 2015
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01865305
Brief Title
Comparison of Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With Diabetes
Official Title
A Randomised, Double-blind, Multiple Period Crossover Trial Comparing Insulin 454 and Insulin Aspart Premixes With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared With Biphasic Insulin Aspart 30 (NovoMix® 30) 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
September 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 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 compare different ratios of explorative formulations, not similar to the proposed commercial formulation, of IDegAsp (co-formulation of insulin degludec/insulin aspart and insulin aspart) with separately injected, simultaneous doses of insulin degludec (insulin 454), and insulin aspart, compared with biphasic insulin aspart 30 in male subjects with type 1 and type 2 diabetes mellitus. Trial part 1 is a five-period cross-over trial with incomplete block-design in subjects with type 1 diabetes where each subject will be randomised to five out of the ten possible treatments. Each treatment consists of an injection of the insulin product followed by a euglycemic clamp with a washout period of 7-15 days between treatments. Trial part 2 is a three-period cross-over trial with complete blockdesign in subjects with type 2 diabetes. Each treatment consists of an injection of the insulin product followed by a euglycaemic clamp with a washout period of 7-15 days between treatments.

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
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trial part 1
Arm Type
Experimental
Arm Title
Trial part 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart 30
Intervention Description
Single dose administrated subcutaneously (s.c., under the skin).
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart 40
Intervention Description
Single dose administrated subcutaneously (s.c., under the skin).
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart 50
Intervention Description
Single dose administrated subcutaneously (s.c., under the skin).
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Single dose administrated subcutaneously (s.c., under the skin).
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Single dose administrated subcutaneously (s.c., under the skin).
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 30
Intervention Description
Single dose administrated subcutaneously (s.c., under the skin) as comparator.
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart 40
Intervention Description
Single dose administrated subcutaneously (s.c., under the skin).
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart 50
Intervention Description
Single dose administrated subcutaneously (s.c., under the skin).
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 30
Intervention Description
Single dose administrated subcutaneously (s.c., under the skin).
Primary Outcome Measure Information:
Title
Area under the insulin aspart concentration curve from 0-2 hours (for subjects with type 1 diabetes)
Time Frame
0-2 hours after dosing
Title
Maximum glucose infusion rate divided by the average glucose infusion rate (for subjects with type 2 diabetes)
Time Frame
0-24 hours after dosing
Secondary Outcome Measure Information:
Title
Area under the glucose infusion rate curve
Time Frame
0-24 hours after dosing
Title
Area under the serum insulin degludec concentration 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
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The subject will be a male volunteer, who is considered to be generally healthy, except for underlying diabetes mellitus and concomitant medical complications (e.g. hypertension) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator Glycosylated haemoglobin A1c (HbA1c) below or equal to 10 % based on central laboratory results ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 1 DIABETES: 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) ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 2 DIABETES: Diagnosed with type 2 diabetes mellitus for at least 12 months Treated with insulin for the last 3 months prior to screening. Body Mass Index (BMI) between 22.0 and 35.0 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 trial product, as judged by the Investigator 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 Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With Diabetes

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