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Completed

NCT Number: NCT01520831

Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Body mass index between 18 and 28 kg/m^2 inclusive
  • HbA1c within the normal laboratory range
  • Non smoker for at least three months
  • Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD) , the oral contraceptive pill or barrier methods

Exclusion criteria

  • Subjects who have received any investigational drug in the 3 months prior to the start of dosing
  • Any disease requiring regular use of non topical prescription medicines
  • Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
  • Any intercurrent illness or endocrine disorders that may affect blood glucose
  • Subject with a history of drug or alcohol dependence
  • Subject with a first degree relative with diabetes mellitus
  • Subject with a history of clinically relevant allergic reactions to medical products
  • Subjects who have donated any blood or plasma in the past 3 month preceding screening

Treatment and study plan

biphasic insulin aspart 30

Drug

One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days

biphasic insulin aspart 50

Drug

One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days

biphasic insulin aspart 70

Drug

One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days

insulin aspart

Drug

One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days

Primary outcomes

  1. Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes

Secondary outcomes

  1. Maximum GIR value

  2. Time to maximum GIR value

  3. Area under the GIR profile

  4. Cmax, maximum insulin aspart concentration

  5. Area under the insulin aspart concentration curve

  6. tmax, the time to maximum insulin aspart concentration

  7. t½, terminal half-life

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Four-period Cross-over Trial in Healthy Subjects, Investigating the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Soluble Insulin Aspart

Important dates

Study start
1999
Primary completion
2000
Study completion
2000
First posted
Jan 30, 2012
Registry last updated
Jan 4, 2017

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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