Safety and Tolerability of NN9068 in Healthy Male Volunteers

A Trial to Test for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9068 and Compared With NN1250 and NN2211 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00983021

Enrollment

Registered

2009-09-23

Start date

2009-09-30

Completion date

2009-12-31

Last updated

2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

Brief 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.

Interventions

DRUGinsulin degludec/liraglutide

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

DRUGinsulin degludec

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

DRUGliraglutide

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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

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

* 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

Design outcomes

Primary

Measure	Time frame
Number and severity of adverse events, number and severity of local tolerability issues at the injection site, number and severity of hypoglycaemic episodes	assessed 0-96 hours after trial product administration

Secondary

Measure	Time frame
The area under the NN2211 concentration-time curve after single-dose	assessed 0-72 hours after trial product administration
The area under the NN1250 concentration-time curve after single-dose	assessed 0-96 hours after trial product administration

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026