Safety and Tolerability of NN9068 in Healthy Male Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Tolerability of Insulin Degludec/Liraglutide (A3) in Healthy Subjects

NCT01319240

Diabetes Healthy

COMPLETED PHASE1

Trial Investigating the Safety of NNC 0113-0987 in Healthy Male Subjects

NCT01405261

Diabetes Diabetes Mellitus, Type 2 Healthy

COMPLETED PHASE1

Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects

NCT01272973

Diabetes Diabetes Mellitus, Type 2 Healthy

COMPLETED PHASE1

Evaluation of Optimal Dosing Conditions for GLP-1 Analogue NNC0113-0987 When Administered Orally in Healthy Male Subjects

NCT02094521

Diabetes Healthy

COMPLETED PHASE1

A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects

NCT01916174

Diabetes Diabetes Mellitus, Type 2 Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

insulin degludec/liraglutide

Intervention Type DRUG

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

placebo

Intervention Type DRUG

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

B

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

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

placebo

Intervention Type DRUG

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

C

Group Type ACTIVE_COMPARATOR

liraglutide

Intervention Type DRUG

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

placebo

Intervention Type DRUG

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

D

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

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

liraglutide

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

insulin degludec/liraglutide

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

Intervention Type DRUG

insulin degludec

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

Intervention Type DRUG

liraglutide

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NN9068 NN1250 NN2211

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No