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A Trial Investigating the Pharmacodynamic Properties of NN5401 in 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
insulin degludec/insulin aspart
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 - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
  • Body mass index (BMI) 18.0-28.0 kg/m^2 (both inclusive)
  • Glycosylated haemoglobin (HbA1c) maximum 9.5 %
  • Fasting C-peptide maximum 0.3 nmol/L

Exclusion Criteria:

  • Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
  • Not able or willing to refrain from smoking, use of nicotine gum or transdermal nicotine patches during the inpatient period
  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IDeg-->IDegAsp

Arm Description

Outcomes

Primary Outcome Measures

Area under the glucose infusion rate curve during one dosing interval

Secondary Outcome Measures

Maximum glucose infusion rate (GIRmax)
Area under the serum insulin degludec concentration-time curve during one dosing interval
Maximum observed serum insulin degludec concentration
Area under the serum insulin aspart concentration-time curve
Maximum observed serum insulin aspart concentration

Full Information

First Posted
April 30, 2012
Last Updated
February 9, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01590836
Brief Title
A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes
Official Title
A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (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 response (the effect of the investigated drug on the body) of insulin degludec/insulin aspart (IDegAsp) at steady state in 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
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDeg-->IDegAsp
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Administered subcutaneously (s.c., under the skin) once daily (plus insulin aspart as bolus insulin as required).
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart
Intervention Description
Single dose administered subcutaneously (s.c., under the skin).
Primary Outcome Measure Information:
Title
Area under the glucose infusion rate curve during one dosing interval
Time Frame
At steady state (0-24 hours)
Secondary Outcome Measure Information:
Title
Maximum glucose infusion rate (GIRmax)
Time Frame
At steady state (within 0-24 hours after last dosing)
Title
Area under the serum insulin degludec concentration-time curve during one dosing interval
Time Frame
At steady state (within 0-24 hours after last dosing)
Title
Maximum observed serum insulin degludec concentration
Time Frame
At steady state (within 0-24 hours after last dosing)
Title
Area under the serum insulin aspart concentration-time curve
Time Frame
From 0 to 12 hours
Title
Maximum observed serum insulin aspart concentration
Time Frame
Within 0-12 hours after dosing of IDegAsp

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months Body mass index (BMI) 18.0-28.0 kg/m^2 (both inclusive) Glycosylated haemoglobin (HbA1c) maximum 9.5 % Fasting C-peptide maximum 0.3 nmol/L Exclusion Criteria: Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) Not able or willing to refrain from smoking, use of nicotine gum or transdermal nicotine patches during the inpatient period Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to 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:
Facility Name
Novo Nordisk Investigational Site
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24888255
Citation
Heise T, Nosek L, Roepstorff C, Chenji S, Klein O, Haahr H. Distinct Prandial and Basal Glucose-Lowering Effects of Insulin Degludec/Insulin Aspart (IDegAsp) at Steady State in Subjects with Type 1 Diabetes Mellitus. Diabetes Ther. 2014 Jun;5(1):255-65. doi: 10.1007/s13300-014-0070-2. Epub 2014 Jun 3.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes

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