Comparison of Insulin Aspart Produced by Current Process... | NCT01620450

Studies
Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese

NCT01620450

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Mar 1, 2017Actual

Enrollment

34Actual

Phase

Phase 1

Conditions

Diabetes
Healthy

Interventions

biphasic human insulin 30

Countries

Japan

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

Feb 2017

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

Nov 20, 2004Actual

Primary Completion Date

Feb 26, 2005Actual

Completion Date

Feb 26, 2005Actual

First Submitted Date

Jun 13, 2012

First Submission Date that Met QC Criteria

Jun 13, 2012

First Posted Date

Jun 15, 2012Estimated

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

Feb 28, 2017

Last Update Posted Date

Mar 1, 2017Actual

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 Japan. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process in healthy Japanese 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

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NN2000	Experimental		Drug: biphasic human insulin 30
NN-X14	Active Comparator		Drug: biphasic human insulin 30

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biphasic human insulin 30	Drug	Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits	NN-X14 NN2000

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h)		From 0 to 16 hours after injection
Maximum insulin aspart concentration (Cmax IAsp)

Secondary Outcomes

Measure	Description	Time Frame
Area under the curve of insulin aspart concentration (AUC IAsp)
Time to maximum insulin aspart concentration (tmax IAsp)
Terminal elimination half life (t½)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Japanese
Considered generally healthy based on medical history and physical examination
Body Mass Index (BMI) between 18 and 27 kg/m^2 (both inclusive)
Fasting plasma glucose between 3.8 mmol/L (68.4 mg/dL) and 6.0 mmol/L (108.0 mg/dL)

Exclusion Criteria:

Clinically significant abnormal values in clinical laboratory tests of haematology, biochemistry, fasting plasma glucose and urinalysis
Any serious systemic infectious disease that occurred during the last 4 weeks before trial
Any inter-current illness that may affect blood glucose
Subject with a first degree relative with diabetes mellitus
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 4 weeks

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 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		Tokyo		1000005	Japan

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
C575870	biphasic human insulin 30

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided