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Completed

NCT Number: NCT01134224

A Trial Investigating the Effect of NN5401 in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to evaluate the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects with type 2 diabetes.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 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 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Body mass index below or equal to 35.0 kg/m^2

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

0.4 U/kg body weight injected subcutaneously (under the skin) once

biphasic insulin aspart 30

Drug

0.4 U/kg body weight injected subcutaneously (under the skin) once

Primary outcomes

  1. Area under the glucose infusion rate curve (only for IDegAsp)

    Time frame: From 0 to 24 hours after single-dose

Secondary outcomes

  1. Area under the insulin aspart concentration-time curve

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

  2. Area under the insulin aspart concentration-time curve (only for BIAsp 30)

    Time frame: From 0 to 24 hours after single-dose administration

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 2 Diabetes

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 31, 2010
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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