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Completed

NCT Number: NCT01620424

Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 Diabetes

This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of biphasic insulin aspart 30 (NN-X14Mix30) and biphasic insulin aspart 50 (NN-X14Mix5050) 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

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • Duration of diabetes for at least 1 year
  • Body Mass Index (BMI) maximum 30.0 kg/m^2
  • HbA1c maximum 10.0%

Exclusion criteria

  • Recurrent severe hypoglycaemia
  • Proliferative or preproliferative retinopathy diagnosed within the last 12 weeks or laser therapy for retinopathy within the last 12 weeks
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac problems
  • Uncontrolled treated / untreated hypertension
  • Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
  • Total daily insulin dose exceeding 40 IU
  • Treatment with OHAs (oral hypoglycaemic agents) or insulin preparations twice or more frequently a day
  • Treatment with OHAs or insulin preparations once a day later than noon
  • Subjects who smoke more than 15 cigarettes per day

Treatment and study plan

biphasic insulin aspart 30

Drug

Single dose administered subcutaneously (s.c., under the skin) on two dosing vists. A wash-out period of 2-28 days will take place between dosing visits

biphasic insulin aspart 50

Drug

Single dose administered subcutaneously (s.c., under the skin) on two dosing vists. A wash-out period of 2-28 days will take place between dosing visits

Primary outcomes

  1. The maximum insulin aspart concentration

Secondary outcomes

  1. The area under the insulin aspart curve

  2. tmax, the time to maximum insulin aspart concentration

  3. t½, terminal half-life

  4. The area under the glucose infusion rate (GIR) profile

  5. GIRmax, maximum glucose infusion rate value

  6. tmaxGIR, time to maximum glucose infusion rate value

  7. The area under the glucose infusion rate profile

  8. Vital signs (blood pressure and pulse)

  9. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Double-blind, Single-centre, Two-Period Crossover Trial Investigating the Pharmacokinetics and Pharmacodynamics of NN-X14Mix30 and NN-X14Mix50 in Type 2 Diabetic Patients

Important dates

Study start
2001
Primary completion
2001
Study completion
2001
First posted
Jun 15, 2012
Registry last updated
Jan 5, 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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