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NCT Number: NCT02933853

A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus

A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects with Type 2 Diabetes Mellitus

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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

Novo Nordisk Investigational Site

Graz, 8010, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. The total number of subjects aged 65-75 years (both inclusive) must NOT exceed 25.
  • Subjects diagnosed (clinically) with type 2 diabetes mellitus for at least 12 months (365 days) prior to the day of screening
  • HbA1C below or equal to 9.5 % based on central laboratory analysis

Exclusion criteria

  • Smoker (defined as a subject who is smoking more than one cigarette or the equivalent per day) who is not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period
  • Surgery or trauma with significant blood loss (more than 500 mL) within the last 90 days prior to screening

Treatment and study plan

Faster-acting insulin aspart

Drug

A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.

insulin aspart

Drug

A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.

Primary outcomes

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

    Time frame: From 0 to 30 minutes

Secondary outcomes

  1. Maximum observed serum insulin aspart concentration

    Time frame: Within 0 to 12 hours after dosing

  2. Area under the glucose infusion rate curve

    Time frame: From 0 to t, where t is the last time where glucose infusion rate (GIR) exceeds zero (within 0 to 12 hours after dosing)

  3. 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

Official study title

This Trial is Conducted in Europe. The Aim of This Trial is to Investigate Pharmacokinetic (the Exposure of the Trial Drug in the Body) and Pharmacodynamic (the Effect of the Investigated Drug on the Body) Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 14, 2016
Registry last updated
May 24, 2019

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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