Within-subject Variability of Insulin Detemir in Healthy... | NCT01497535

Studies
Within-subject Variability of Insulin Detemir in Healthy Volunteers

NCT01497535

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Feb 24, 2017Actual

Enrollment

40Actual

Phase

Phase 1

Conditions

Diabetes
Healthy

Interventions

insulin detemir
insulin glargine

Countries

Germany

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

May 27, 2004Actual

Primary Completion Date

Oct 31, 2004Actual

Completion Date

Oct 31, 2004Actual

First Submitted Date

Dec 20, 2011

First Submission Date that Met QC Criteria

Dec 20, 2011

First Posted Date

Dec 22, 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 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 Europe. The aim of this trial is to compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers.

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Insulin detemir	Experimental		Drug: insulin detemir
Insulin glargine	Active Comparator		Drug: insulin glargine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin detemir	Drug	On four different dosing days where subjects enter a 24-hour euglycaemic glucose clamp procedure, the subject will be allocated to one single dose of either 0.4 U/kg insulin detemir or 0.4 U/kg insulin glargine administered subcutaneously (s.c., under the skin)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum glucose infusion rate (GIRmax)

Secondary Outcomes

Measure	Description	Time Frame
Area under the glucose infusion rate curve (AUCGIR)
Time to maximum glucose infusion rate (tGIRmax)
Area under the insulin concentration curve (AUC)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy Japanese men or women
Holding a Japanese pass-port and Japanese-born parents
Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
Body Mass Index (BMI) between 18 and 30 kg/m^2, incl.
Fasting blood glucose maximum 6 mmol/L

Exclusion Criteria:

Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
Any serious systemic infectious disease that occurred during the four weeks prior to the first dose of the trial product, as judged by the Investigator
Subject with history of alcohol or drug dependence

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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		Neuss		41460	Germany

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
D000069036	Insulin Glargine

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided