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OpenTrials
Completed

NCT Number: NCT00983021

Safety and Tolerability of NN9068 in Healthy Male Volunteers

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin degludec/liraglutide

Drug

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

Other names: NN9068

insulin degludec

Drug

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

Other names: NN1250

liraglutide

Drug

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

Other names: NN2211

Placebo

Drug

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

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 23, 2009
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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