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CompletedNCT01121289Updated Dec 10, 2013

A Trial Investigating NN1218 in Subjects With Type 1 Diabetes

A Phase 1 interventional study of NN1218 and insulin aspart in Diabetes and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-12-10.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This trial is conducted in Europe. The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 diabetes.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 1
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 26 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 1 diabetes mellitus for more than 12 months
  • Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months
  • Body mass index (BMI) between 18.0-28.0 kg/m2 (both inclusive)

Exclusion criteria

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 gum or transdermal nicotine patches during the inpatient period
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    NN1218, formulation A

    Drug: NN1218

  • Experimental
    NN1218, formulation B

    Drug: NN1218

  • Experimental
    NN1218, formulation B (high)

    Drug: NN1218

  • Experimental
    NN1218, formulation C

    Drug: NN1218

  • Experimental
    NN1218, formulation D

    Drug: NN1218

  • Active comparator
    insulin aspart

    Drug: insulin aspart

Interventions

  • DrugNN1218

    0.2 U/kg body weight injected subcutaneously (under the skin)

  • Druginsulin aspart

    0.2 U/kg body weight injected subcutaneously (under the skin)

  • DrugNN1218

    0.2 U/kg body weight injected subcutaneously (under the skin)

  • DrugNN1218

    0.4 U/kg body weight injected subcutaneously (under the skin)

  • DrugNN1218

    0.2 U/kg body weight injected subcutaneously (under the skin)

  • DrugNN1218

    0.2 U/kg body weight injected subcutaneously (under the skin)

06

What researchers measure

Primary outcomes

  1. Area under the serum NN1218 concentration-time curve

    Time frame: From 0-1 hours

Secondary outcomes

  1. Area under the serum NN1218 concentration-time curve

    Time frame: From 0-10 hours

07

Study locations

1 site
  • Neuss, 41460, Germany
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01121289
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
May 12, 2010
Start date
Apr 2010
Primary completion
Jul 2010
Completion
Jul 2010
Last update
Dec 10, 2013

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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