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Completed

NCT Number: NCT01618188

A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic properties (the effect of the investigated drug on the body) of NN1218 in subjects with type 1 diabetes.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

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

  • Type 1 diabetes mellitus for more than 12 months
  • Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion for more than 12 months
  • Body mass index (BMI) between 18.0-28.0 kg/m^2 (both inclusive)

Exclusion criteria

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
  • Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
  • Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

Treatment and study plan

Faster-acting insulin aspart

Drug

A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.

Other names: NN1218

insulin aspart

Drug

A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.

Primary outcomes

  1. Area under the glucose infusion rate curve

    Time frame: From 0 to 2 hours

Secondary outcomes

  1. Area under the glucose infusion rate curve

    Time frame: From 0 to 12 hours

  2. Maximum glucose infusion rate

    Time frame: Within 0 to 12 hours after dosing

  3. Time to maximum glucose infusion rate

    Time frame: Within 0 to 12 hours after dosing

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 13, 2012
Registry last updated
Dec 11, 2018

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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