Pharmacokinetics of Insulin Detemir in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542450
• Other study ID #: NN304-1475
• Secondary ID: JapicCTI-R070015
• Status: Completed
• Phase: Phase 1
• First received: February 24, 2012
• Last updated: January 26, 2017
• Start date: August 2002
• Est. completion date: February 2003

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2003
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin detemir
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
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

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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): 3

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ratio of area under the glucose infusion rate curve (AUCGIR) 0-5 hours to AUCGIR 0-24 hours
Secondary	AUCGIR, area under the glucose infusion rate value curve
Secondary	GIRmax, the maximum GIR value
Secondary	tmax GIR, time to maximum GIR value
Secondary	Cmax, maximum concentration
Secondary	Area under the curve
Secondary	tmax, time to maximum concentration
Secondary	MRT, mean residence time
Secondary	t½, terminal half-life
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk