Clinical trial NCT01542450: Pharmacokinetics of Insulin Detemir in Subjects With Type 1 Diabetes
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-02
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The ratio of area under the glucose infusion rate curve (AUCGIR) 0-5 hours to AUCGIR 0-24 hours
Secondary outcomes:
measure: AUCGIR, area under the glucose infusion rate value curve
measure: GIRmax, the maximum GIR value
measure: tmax GIR, time to maximum GIR value
measure: Cmax, maximum concentration
measure: Area under the curve
measure: tmax, time to maximum concentration
measure: MRT, mean residence time
measure: t½, terminal half-life
measure: Adverse events
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Irie S, Matsumura Y, Hirano K. Pharmacokinetics and Pharmacodynamics of Single Dose Insulin Detemir, Long-acting soluble insulin analogue compared to NPH insulin in Patients with type 1 Diabetes Mellitus. Journal of Clinical Ther. and Med. 2007; 5 (23): 349-356