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Completed

NCT Number: NCT01542450

Pharmacokinetics of Insulin Detemir in Subjects With Type 1 Diabetes

This trial is conducted in Japan. The aim for this trial is to investigate the pharmacodynamics and pharmacokinetics of insulin detemir and insulin NPH in Japanese subjects with type 1 diabetes mellitus.

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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

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 1 diabetes mellitus
  • HbA1c (glycosylated haemoglobin) maximum 9.0%
  • Duration of diabetes at least 1 year
  • Body Mass Index (BMI) maximum 25.0 kg/m^2

Exclusion criteria

  • Recurrent severe hypoglycaemia
  • Proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator
  • 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
  • Known or suspected allergy against the trial products or related products including the components
  • Previous history of serious allergy or anaphylactic reaction
  • Any disease or condition which the Investigator feel would interfere with the trial participation or evaluation of the results
  • Severe late-phase diabetic complications including nephropathy
  • Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 3 weeks
  • Known or suspected alcohol and illicit substance abuse or dependence
  • Pregnancy, breast-feeding (within a year after labour) or the intention to become pregnant
  • The receipt of any investigational drug within the last 12 weeks prior to this trial
  • Current or anticipated treatment with systemic corticosteroids

Treatment and study plan

insulin detemir

Drug

Single dose of 0.3 U/kg administered subcutaneously (s.c. under the skin) in each treatment period separated by a washout period of 4-28 days

insulin NPH

Drug

Single dose of 0.3 U/kg administered subcutaneously (s.c. under the skin) in each treatment period separated by a washout period of 4-28 days

Primary outcomes

  1. The ratio of area under the glucose infusion rate curve (AUCGIR) 0-5 hours to AUCGIR 0-24 hours

Secondary outcomes

  1. AUCGIR, area under the glucose infusion rate value curve

  2. GIRmax, the maximum GIR value

  3. tmax GIR, time to maximum GIR value

  4. Cmax, maximum concentration

  5. Area under the curve

  6. tmax, time to maximum concentration

  7. MRT, mean residence time

  8. t½, terminal half-life

  9. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Open-labelled, Single-centre, Two-period Crossover Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single s.c. Doses of NN304 (Insulin Detemir) and NPH Human Insulin in Japanese Subjects With Type 1 Diabetes Mellitus

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Mar 2, 2012
Registry last updated
Jan 27, 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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