Pharmacokinetics of Insulin Detemir in Healthy Chinese Ma... | NCT01498939

Studies
Pharmacokinetics of Insulin Detemir in Healthy Chinese Male Subjects

NCT01498939

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Oct 28, 2016Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Diabetes
Healthy

Interventions

insulin detemir

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Sep 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Dec 21, 2011

First Submission Date that Met QC Criteria

Dec 21, 2011

First Posted Date

Dec 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2016

Last Update Posted Date

Oct 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetics after a single dose of insulin detemir in healthy Chinese male subjects.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
IDet 0.2 U/kg	Experimental	Drug: insulin detemir
IDet 0.4 U/kg	Experimental	Drug: insulin detemir
IDet 0.8 U/kg	Experimental	Drug: insulin detemir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin detemir	Drug	Each subject will be randomly allocated to an insulin detemir dosing sequence. Three doses of insulin detemir (0.2, 0.4 or 0.8 U/kg) will be administered on three inconsecutive days with a wash-out period between each dosing. Injected subcutaneously (s.c., under the skin)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the insulin detemir concentration curve		from time zero to 24 hour

Secondary Outcomes

Measure	Description	Time Frame
Area under the insulin detemir concentration curve
Maximum serum insulin detemir concentration
Time to maximum serum insulin detemir concentration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body mass index (BMI) between 18 and 25 kg/m^2 (both inclusive)
Fasting plasma glucose maximum 6 mmol/L
Non-smoker
Considered generally healthy upon completion of medical history, physical examination and laboratory assessments, as judged by the Investigator

Exclusion Criteria:

Known or suspected allergy to trial product(s) or related products
Previous participation in this trial. Participation is defined as randomisation
Receipt of any investigational drug within the last three months prior to this trial
History of alcohol or drug abuse

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Beijing	Beijing Municipality	100032	China

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069057	Insulin Detemir

Ancestor Terms

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided