Bioequivalence of Two Formulations of Biphasic Insulin As... | NCT01527552

Studies
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects

NCT01527552

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Feb 24, 2017Actual

Enrollment

30Actual

Phase

Phase 1

Conditions

Diabetes
Healthy

Interventions

biphasic insulin aspart 50

Countries

South Africa

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 5, 2002Actual

Primary Completion Date

Dec 18, 2002Actual

Completion Date

Dec 18, 2002Actual

First Submitted Date

Feb 2, 2012

First Submission Date that Met QC Criteria

Feb 2, 2012

First Posted Date

Feb 7, 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 22, 2017

Last Update Posted Date

Feb 24, 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 Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 in healthy 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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Formulation A	Experimental		Drug: biphasic insulin aspart 50
Formulation B	Experimental		Drug: biphasic insulin aspart 50

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biphasic insulin aspart 50	Drug	A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the insulin aspart curve in the interval from 0-16 hours
Cmax, maximum insulin aspart concentration

Secondary Outcomes

Measure	Description	Time Frame
tmax, the time to maximum insulin aspart concentration
Area under the insulin aspart curve
Mean residence time (MRT)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Considered generally healthy upon completion of medical history and physical examination, as judged by the investigator
Body Mass Index (BMI) between 19-29 kg/m^2 (both inclusive)
Minimum body weight of 65 kg
Fasting blood glucose between 3.8-6.0 mmol/L
Glycohemoglobin (HbA1c) below 6.4 %
Non-smokers

Exclusion Criteria:

Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject
History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen)
Hepatitis B or C
Subjects with a first-degree relative with diabetes mellitus
Known or suspected allergy to trial product or related products
Smoking during the past three months

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 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		Bloemfontein		9324	South Africa

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