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Completed

NCT Number: NCT01455142

A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and safety obtained with formulation 1 can be assumed identical for formulation 2.

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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

Graz, 8010, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
  • Body mass index from 18.0 to 28.0 kg/m^2 (both inclusive)
  • HbA1c below or equal to 9.5% by central laboratory analysis

Exclusion criteria

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • 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 gum or transdermal nicotine patches during the inpatient period

Treatment and study plan

insulin degludec/insulin aspart

Drug

Single injection of each formulation. The dose level will be 0.5 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).

Other names: IDegAsp

Primary outcomes

  1. Area under the serum insulin degludec concentration-time curve

    Time frame: From 0 to 120 hours after single-dose (SD)

  2. Maximum observed serum insulin degludec concentration

    Time frame: After single-dose (within 0 to 120 hours after dosing)

  3. Area under the serum insulin aspart concentration-time curve

    Time frame: From 0 to 12 hours after single-dose

  4. Maximum observed serum insulin aspart concentration

    Time frame: After single-dose (within 0 to 12 hours after dosing)

Secondary outcomes

  1. Area under the glucose infusion rate curve

    Time frame: From 0 to 26 hours after single-dose

  2. Maximum glucose infusion rate

    Time frame: After single-dose (within 0 to 120 hours after dosing)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 19, 2011
Registry last updated
Feb 23, 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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