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Completed

NCT Number: NCT00992537

Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Type 1 Diabetics

This trial is conducted in Europe. The aim of this clinical trial is to compare the blood glucose lowering effect of NN5401(insulin degludec/insulin aspart (IDegAsp)) with NN1250 (insulin degludec (IDeg)) and insulin aspart (IAsp) in subjects with type 1 diabetes where the trial participant will receive one single dose of each trial product in varying order.

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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–65 year

Sex eligibility

All sexes

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

  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Body mass index 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 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

Drug

Insulin degludec single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).

insulin degludec/insulin aspart

Drug

Insulin degludec/insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).

insulin aspart

Drug

Insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).

Primary outcomes

  1. Area under the glucose infusion rate curve

    Time frame: From 0 to 6 hours after single-dose administration

  2. Area under the glucose infusion rate curve

    Time frame: From 4 to 24 hours after single-dose administration

Secondary outcomes

  1. Area under the insulin degludec concentration-time curve

    Time frame: From 0 to 120 hours after single-dose administration

  2. Maximum observed insulin degludec concentration

    Time frame: From 0 to 120 hours after single-dose administration

  3. Area under the insulin aspart concentration-time curve

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

  4. Maximum observed insulin aspart concentration

    Time frame: 0-12 hours after single-dose administration

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties Between NN5401 and NN1250 and Between NN5401 and Insulin Aspart in Subjects With Type 1 Diabetes

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 9, 2009
Registry last updated
Nov 27, 2013

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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