search
Back to results

A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Faster-acting insulin aspart
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 - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 1 diabetes mellitus for more than 12 months
  • Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion for more than 12 months
  • Body mass index (BMI) between 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 trial start
  • 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 substitute products during the inpatient period

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Formulation A

Formulation B

Insulin Aspart

Arm Description

Outcomes

Primary Outcome Measures

Area under the glucose infusion rate curve

Secondary Outcome Measures

Area under the glucose infusion rate curve
Maximum glucose infusion rate
Time to maximum glucose infusion rate

Full Information

First Posted
June 11, 2012
Last Updated
December 7, 2018
Sponsor
Novo Nordisk A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT01618188
Brief Title
A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes
Official Title
A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 11, 2012 (Actual)
Primary Completion Date
September 7, 2012 (Actual)
Study Completion Date
September 7, 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 properties (the effect of the investigated drug on the body) of NN1218 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
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Formulation A
Arm Type
Experimental
Arm Title
Formulation B
Arm Type
Experimental
Arm Title
Insulin Aspart
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Faster-acting insulin aspart
Other Intervention Name(s)
NN1218
Intervention Description
A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.
Primary Outcome Measure Information:
Title
Area under the glucose infusion rate curve
Time Frame
From 0 to 2 hours
Secondary Outcome Measure Information:
Title
Area under the glucose infusion rate curve
Time Frame
From 0 to 12 hours
Title
Maximum glucose infusion rate
Time Frame
Within 0 to 12 hours after dosing
Title
Time to maximum glucose infusion rate
Time Frame
Within 0 to 12 hours after dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 diabetes mellitus for more than 12 months Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion for more than 12 months Body mass index (BMI) between 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 trial start 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 substitute products 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
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25846340
Citation
Heise T, Hovelmann U, Brondsted L, Adrian CL, Nosek L, Haahr H. Faster-acting insulin aspart: earlier onset of appearance and greater early pharmacokinetic and pharmacodynamic effects than insulin aspart. Diabetes Obes Metab. 2015 Jul;17(7):682-8. doi: 10.1111/dom.12468. Epub 2015 May 8.
Results Reference
background
Citation
Haahr H, Hövelmann U, Brøndsted L, Adrian CL, Nosek L, Heise T. Higher Early Insulin Exposure and Greater Early Glucose-lowering Effect with Faster-acting Insulin Aspart in Patients with Type 1 Diabetes Mellitus (T1DM). Diabetes 2014; 63 ((Suppl 1)): A233 (abstract 910-P)
Results Reference
background
Citation
Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. Faster Onset and Greater Early Exposure and Glucose-Lowering Effect with Faster-Acting Insulin Aspart vs. Insulin Aspart: A Pooled Analysis in Subjects with Type 1 Diabetes. Diabetes. 2016; Suppl. 1: A239. doi:10.2337/db16-861-1374 http://dx.doi.org/10.2337/db16-861-1374
Results Reference
background
PubMed Identifier
30402720
Citation
Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T. Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2019 May;58(5):639-649. doi: 10.1007/s40262-018-0718-6.
Results Reference
result
PubMed Identifier
28205039
Citation
Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. A Pooled Analysis of Clinical Pharmacology Trials Investigating the Pharmacokinetic and Pharmacodynamic Characteristics of Fast-Acting Insulin Aspart in Adults with Type 1 Diabetes. Clin Pharmacokinet. 2017 May;56(5):551-559. doi: 10.1007/s40262-017-0514-8.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes

We'll reach out to this number within 24 hrs