Pharmacokinetics of Insulin Detemir in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 1

Diabetes

Treatments

Drug: insulin NPH

Drug: insulin detemir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01542450

JapicCTI-R070015 (Registry Identifier)

NN304-1475

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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