A Trial Investigating NN1218 in Subjects With Type 1 and Type 2 Diabetes
A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 and Type 2 Diabetes
3 other identifiers
interventional
82
1 country
1
Brief Summary
This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 and type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 10, 2010
CompletedFirst Posted
Study publicly available on registry
May 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedJanuary 18, 2017
January 1, 2017
5 months
May 10, 2010
January 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the blood glucose concentration-time curve
from 0-2 hours
Secondary Outcomes (1)
Area under the blood glucose concentration-time curve
from 0-6 hours
Study Arms (5)
NN1218, formulation A
EXPERIMENTALNN1218, formulation B
EXPERIMENTALNN1218, formulation C
EXPERIMENTALNN1218, formulation D
EXPERIMENTALinsulin aspart
ACTIVE COMPARATORInterventions
0.2 U/kg body weight injected subcutaneously (under the skin)
Eligibility Criteria
You may qualify if:
- Type 1 or type 2 diabetes mellitus for more than 12 months
- Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for 12 months or longer for subjects with type 1 diabetes and for 3 months or longer for subjects with type 2 diabetes
- Body Mass Index (BMI) between 18.0-32.0 kg/m2 (both inclusive)
You may not qualify if:
- Surgery or trauma with significant blood loss (more than 500 mL) within the last 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 gum or transdermal nicotine patches during the inpatient period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Chula Vista, California, 91911, United States
Related Publications (1)
Heise T, Haahr H, Jensen L, Ericsen L, Hompesch M. Faster-acting Insulin Aspart Improves Postprandial Glycemia vs Insulin Aspart in Patients with Type 1 Diabetes Mellitus (T1DM). Diabetes 2014; 63 ((Suppl 1)): A34 (abstract 129-OR)
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2010
First Posted
May 12, 2010
Study Start
April 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
January 18, 2017
Record last verified: 2017-01