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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

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

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

NCT ID

NCT01865318

First Posted

May 27, 2013

Last Updated

October 21, 2015

Sponsor

Novo Nordisk A/S

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

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

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

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