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CompletedNCT00983021Updated Feb 8, 2017

Safety and Tolerability of NN9068 in Healthy Male Volunteers

A Phase 1 interventional study of insulin degludec/liraglutide and insulin degludec in Diabetes and Healthy, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to male participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-02-08.

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

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, level of drug exposure and effect of NN9068.

The trial participants will be randomised to 4 different treatments in trial, receiving trial products in a pre-defined order.

02

Conditions studied

  • Diabetes
  • Healthy
03

In context

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 55 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Male subjects, who are considered to be generally healthy, based on an assessment of medical history, physical examination, and clinical laboratory data, as judged by the Investigator.
  • Body mass index (BMI) between 18.0 and 27.0 kg/m2 (both inclusive)
  • Body weight between 60 kg and 90 kg (both inclusive)

Exclusion criteria

Exclusion Criteria:

  • Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the current trial, as judged by the Investigator
05

Study design

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

Study arms

  • Experimental
    A

    Drug: insulin degludec/liraglutide · Drug: placebo

  • Experimental
    B

    Drug: insulin degludec · Drug: placebo

  • Active comparator
    C

    Drug: liraglutide · Drug: placebo

  • Experimental
    D

    Drug: insulin degludec · Drug: liraglutide

Interventions

  • Druginsulin degludec/liraglutide

    Single, simultaneous dose of NN9068, injected s.c. (under the skin)

    Also known as: NN9068

  • Druginsulin degludec

    Single, simultaneous dose of NN1250, injected s.c. (under the skin)

    Also known as: NN1250

  • Drugliraglutide

    Single, simultaneous dose of NN2211, injected s.c. (under the skin)

    Also known as: NN2211

  • Drugplacebo

    Single, simultaneous dose of placebo, injected s.c. (under the skin)

06

What researchers measure

Primary outcomes

  1. Number and severity of adverse events, number and severity of local tolerability issues at the injection site, number and severity of hypoglycaemic episodes

    Time frame: assessed 0-96 hours after trial product administration

Secondary outcomes

  1. The area under the NN2211 concentration-time curve after single-dose

    Time frame: assessed 0-72 hours after trial product administration

  2. The area under the NN1250 concentration-time curve after single-dose

    Time frame: assessed 0-96 hours after trial product administration

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Neuss, 41460, Germany
08

References and documents

Publications

  • Kapitza C, Bode B, Ingwersen SH, Jacobsen LV, Poulsen P. Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy. J Clin Pharmacol. 2015 Dec;55(12):1369-77. doi: 10.1002/jcph.549. Epub 2015 Jul 14. PubMed 25998481 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00983021
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Sep 23, 2009
Start date
Sep 2009
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Feb 8, 2017

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 Feb 2017. You cannot join it, but the record below documents what was studied.

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