NCT01542450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Aug 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

February 24, 2012

Last Update Submit

January 26, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Treatment period 1

EXPERIMENTAL
Drug: insulin detemirDrug: insulin NPH

Treatment period 2

ACTIVE COMPARATOR
Drug: insulin detemirDrug: insulin NPH

Interventions

insulin detemirDRUG

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

Treatment period 1Treatment period 2
insulin NPHDRUG

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

Treatment period 1Treatment period 2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Related 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): 349-356

    RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

Insulin DetemirInsulin, Isophane

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2012

First Posted

March 2, 2012

Study Start

August 1, 2002

Primary Completion

February 1, 2003

Study Completion

February 1, 2003

Last Updated

January 27, 2017

Record last verified: 2017-01

Locations

JP(1)