Investigating the Pharmacokinetic Properties of NN1250 in... | NCT01437592

Studies
Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects

NCT01437592

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

May 30, 2019Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Diabetes
Healthy

Interventions

insulin degludec

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

ID	Type	Description	Link
U1111-1122-6475	Other Identifier	WHO

Status Module

Record Verification Date

May 2019

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

Sep 6, 2011Actual

Primary Completion Date

Nov 22, 2011Actual

Completion Date

Nov 22, 2011Actual

First Submitted Date

Sep 9, 2011

First Submission Date that Met QC Criteria

Sep 20, 2011

First Posted Date

Sep 21, 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

May 28, 2019

Last Update Posted Date

May 30, 2019Actual

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 was conducted in Asia. The aim of this trial was to investigate the pharmacokinetic properties (the effect of the investigated drug on the body) of NN1250 (insulin degludec) in healthy Chinese 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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IDeg	Experimental		Drug: insulin degludec

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec	Drug	For each subject, a single dose of NN1250 will be administered subcutaneously (under the skin)	IDeg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the serum insulin degludec concentration-time curve		From 0 to 120 hours after single dose

Secondary Outcomes

Measure	Description	Time Frame
Maximum observed serum insulin degludec concentration		0-24 hours (derived on treatment day 1).
Time to maximum observed serum insulin degludec concentration		0-24 hours (derived on treatment day 1).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female Chinese subject aged 18-45 years (both inclusive)
Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator
Body mass index 19.0-24.0 kg/m^2 (both inclusive)

Exclusion Criteria:

A history of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial product to the subject
Subject who has donated any blood or plasma in the past month or more than 400 mL within 3 months prior to screening
Not able or willing to refrain from smoking during the inpatient period

Accepts Healthy Volunteers

Sex

All

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Pei H, Jiang J, Bardtrum L, Haahr H. Pharmacokinetic properties of insulin degludec in healthy Chinese subjects. Diabetes Manag 2019;9(1):20-7

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