Comparison of Human Insulin Produced by the Current Proce... | NCT01448070

Studies
Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Healthy Volunteers

NCT01448070

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Feb 27, 2017Actual

Enrollment

28Actual

Phase

Phase 1

Conditions

Diabetes
Healthy

Interventions

human insulin

Countries

United Kingdom

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

Oct 15, 2002Actual

Primary Completion Date

Dec 20, 2002Actual

Completion Date

Dec 20, 2002Actual

First Submitted Date

Oct 5, 2011

First Submission Date that Met QC Criteria

Oct 5, 2011

First Posted Date

Oct 7, 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

Feb 23, 2017

Last Update Posted Date

Feb 27, 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 Europe. The aim of this trial is to show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®.

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

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NN729 manufacturing process	Experimental		Drug: human insulin
Current manufacturing process	Active Comparator		Drug: human insulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
human insulin	Drug	Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)	Current manufacturing process NN729 manufacturing process

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC (area under the curve) 0-8h (human insulin)
Cmax (maximum plasma concentration)
Area under the curve (glucose infusion rate (GIR)), 0-8h

Secondary Outcomes

Measure	Description	Time Frame
tmax (time to reach maximum)
t½ (terminal half-life)
GIR (glucose infusion rate) max

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
Fasting blood glucose below or equal to 6 mmol/L
Body Mass Index (BMI) 22.0-27.0 kg/m^2 (both inclusive)

Exclusion Criteria:

Participated in another clinical study with an investigational drug within the last 4 weeks
Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable
Known or suspected allergy to the trial product or related products
Family history of type 1 diabetes

Accepts Healthy Volunteers

Yes

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		Manchester		M15 6SH	United Kingdom

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
D007328	Insulin

Ancestor Terms

ID	Term
D011384	Proinsulin
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided