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Completed

NCT Number: NCT01865318

Investigation of Pharmacodynamic Characteristics of Explorative Formulation of Insulin Degludec in Male Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, under single-dose and steady-state conditions in male 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–69 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
  • Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months
  • Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
  • Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results

Exclusion criteria

  • History of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator
  • Participation in any other trials involving investigational products within 3 months preceding the start of dosing

Treatment and study plan

insulin degludec

Drug

Administered subcutaneously (s.c., under the skin)

Primary outcomes

  1. Area under the glucose infusion rate curve

    Time frame: 0-24 hours after dosing

Secondary outcomes

  1. Maximum glucose infusion rate (GIRmax)

    Time frame: 0-24 hours after dosing

  2. Time to maximum glucose infusion rate (tGIRmax)

    Time frame: 0-24 hours after dosing

  3. Area under the serum insulin degludec curve

    Time frame: 0-96 hours after dosing

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Single Centre, Open-Label, Multiple Dose Trial Examining the Pharmacodynamic Characteristics of Insulin 454 Under Single-Dose and Steady-State Conditions in Male Subjects With Type 1 Diabetes

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 30, 2013
Registry last updated
Oct 22, 2015

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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