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Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
insulin degludec
insulin degludec
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
  • Body mass index 18.0-28.0 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • 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 and use of nicotine gum or transdermal nicotine patches during the inpatient period

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

IDeg 100 U/mL

IDeg 200 U/mL

Arm Description

Outcomes

Primary Outcome Measures

Area under the glucose infusion rate curve during one dosing interval at steady-date"

Secondary Outcome Measures

Area under the serum Insulin Degludec concentration-time curve
Area under the serum Insulin Degludec concentration-time curve

Full Information

First Posted
February 24, 2010
Last Updated
January 20, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01076634
Brief Title
Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes
Official Title
A Trial Investigating the Pharmacodynamic Properties of NN1250 in Subjects With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (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 the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations 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
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDeg 100 U/mL
Arm Type
Experimental
Arm Title
IDeg 200 U/mL
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.
Primary Outcome Measure Information:
Title
Area under the glucose infusion rate curve during one dosing interval at steady-date"
Time Frame
After 8 days of treatment
Secondary Outcome Measure Information:
Title
Area under the serum Insulin Degludec concentration-time curve
Time Frame
During one dosing interval at steady state
Title
Area under the serum Insulin Degludec concentration-time curve
Time Frame
From 0 to 24 hours after single dose

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 Body mass index 18.0-28.0 kg/m^2 (both inclusive) Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening 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 and use of nicotine gum or transdermal nicotine patches during the inpatient period
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
Graz
ZIP/Postal Code
8010
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
23749405
Citation
Korsatko S, Deller S, Koehler G, Mader JK, Neubauer K, Adrian CL, Thomsen H, Haahr H, Pieber TR. A comparison of the steady-state pharmacokinetic and pharmacodynamic profiles of 100 and 200 U/mL formulations of ultra-long-acting insulin degludec. Clin Drug Investig. 2013 Jul;33(7):515-21. doi: 10.1007/s40261-013-0096-7.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes

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