Safety and Tolerability of NN9068 in Healthy Male Volunteers

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: insulin degludec/liraglutide
* Drug: insulin degludec
* Drug: liraglutide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: insulin degludec/liraglutide<br>* Single, simultaneous dose of NN9068, injected s.c. (under the skin)<br>* Other names: NN9068;Drug: placebo<br>* Single, simultaneous dose of placebo, injected s.c. (under the skin)<br>|
| Experimental: B<br> | Drug: insulin degludec<br>* Single, simultaneous dose of NN1250, injected s.c. (under the skin)<br>* Other names: NN1250;Drug: placebo<br>* Single, simultaneous dose of placebo, injected s.c. (under the skin)<br>|
| Active Comparator: C<br> | Drug: liraglutide<br>* Single, simultaneous dose of NN2211, injected s.c. (under the skin)<br>* Other names: NN2211;Drug: placebo<br>* Single, simultaneous dose of placebo, injected s.c. (under the skin)<br>|
| Experimental: D<br> | Drug: insulin degludec<br>* Single, simultaneous dose of NN1250, injected s.c. (under the skin)<br>* Other names: NN1250;Drug: liraglutide<br>* Single, simultaneous dose of NN2211, injected s.c. (under the skin)<br>* Other names: NN2211;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |