Safety and Tolerability of NN9068 in Healthy Male Volunteers

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: placebo; Drug: insulin degludec/liraglutide; Drug: liraglutide; Drug: insulin degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT00983021

U1111-1111-8859 (Other Identifier)

NN9068-3632

2009-011269-95 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 4 patient groups

A

Experimental group

Treatment:

Drug: placebo

Drug: insulin degludec/liraglutide

B

Experimental group

Treatment:

Drug: insulin degludec

Drug: placebo

C

Active Comparator group

Treatment:

Drug: liraglutide

Drug: placebo

D

Experimental group

Treatment:

Drug: liraglutide

Drug: insulin degludec