Applications Site Reactions After Injection of Insulin De... | NCT00607737

Studies
Applications Site Reactions After Injection of Insulin Detemir and Saline in Subjects With Diabetes

NCT00607737

Sponsor

Lise Tarnow

Status

Completed

Last Update Posted

Sep 3, 2012Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Diabetes Mellitus

Interventions

insulin detemir
saline

Countries

Denmark

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
EudraCT 2007-005677-59

Status Module

Record Verification Date

Aug 2012

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

Jan 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Jul 2010Actual

First Submitted Date

Jan 23, 2008

First Submission Date that Met QC Criteria

Feb 5, 2008

First Posted Date

Feb 6, 2008Estimated

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

Aug 31, 2012

Last Update Posted Date

Sep 3, 2012Estimated

Name	Class
Novo Nordisk A/S	INDUSTRY

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

To compare application site reactions after superficial and deep subcutaneous and intradermal injections of insulin detemir and saline in patients with diabetes

- The patient serves as his own control, n=100 patients with diabetes

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 4

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
1	Experimental	insulin detemir	Drug: insulin detemir
2	Placebo Comparator	saline	Drug: saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin detemir	Drug	3 cutaneous injections	1
saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
laser doppler blood flow		10 minutes - 7 days

Secondary Outcomes

Measure	Description	Time Frame
clinical signs		10 min - 7 days
insulin detemir specific antibodies		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetes mellitus
HbA1c<11 %
BMI: 20-35 kg/m2
Insulin detemir naive
Basal insulin dose>20E

Exclusion Criteria:

Known allergy to study drug
Current steroid or antiallergic treatment
Lipodystrophy
Change in insulin and antihypertensive treatment < 30 days
Smokers or alcoholics

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
LIse Tarnow, md	Steno Diabetes Center Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Steno Diabetes Center		Gentofte Municipality		2820	Denmark

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
D012965	Sodium Chloride

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided