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Pharmacokinetics of Insulin Detemir in Subjects With Type 1 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
insulin detemir
insulin NPH
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment period 1

Treatment period 2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

AUCGIR, area under the glucose infusion rate value curve
GIRmax, the maximum GIR value
tmax GIR, time to maximum GIR value
Cmax, maximum concentration
Area under the curve
tmax, time to maximum concentration
MRT, mean residence time
t½, terminal half-life
Adverse events

Full Information

First Posted
February 24, 2012
Last Updated
January 26, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01542450
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
February 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment period 1
Arm Type
Experimental
Arm Title
Treatment period 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Intervention Description
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 Outcome Measure Information:
Title
The ratio of area under the glucose infusion rate curve (AUCGIR) 0-5 hours to AUCGIR 0-24 hours
Secondary Outcome Measure Information:
Title
AUCGIR, area under the glucose infusion rate value curve
Title
GIRmax, the maximum GIR value
Title
tmax GIR, time to maximum GIR value
Title
Cmax, maximum concentration
Title
Area under the curve
Title
tmax, time to maximum concentration
Title
MRT, mean residence time
Title
t½, terminal half-life
Title
Adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
1000005
Country
Japan

12. IPD Sharing Statement

Citations:
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
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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Pharmacokinetics of Insulin Detemir in Subjects With Type 1 Diabetes

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