Comparison of Human Insulin to Insulin Inhalation Solutio... | NCT00567775

Studies
Comparison of Human Insulin to Insulin Inhalation Solution in Children With Type 1 Diabetes

NCT00567775

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Mar 1, 2017Actual

Enrollment

27Actual

Phase

Phase 2

Conditions

Diabetes
Diabetes Mellitus, Type 1

Interventions

human insulin
inhaled human insulin

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

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 21, 2002Actual

Primary Completion Date

Nov 20, 2002Actual

Completion Date

Nov 20, 2002Actual

First Submitted Date

Nov 30, 2007

First Submission Date that Met QC Criteria

Dec 4, 2007

First Posted Date

Dec 5, 2007Estimated

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 Europe. The aim of this trial is to compare the pharmacokinetic profile of two different methods of insulin administration in children with type 1 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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Name	Type	Description	Arm Group Labels	Other Names
human insulin	Drug			Actrapid® Novolin® R
inhaled human insulin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the serum insulin curve		from 0 to 5 hours post-dosing

Secondary Outcomes

Measure	Description	Time Frame
Maximum serum insulin concentration		in the interval from 0 to 5 hours post-dosing
Time to maximum serum insulin concentration		in the interval from 0 to 5 hours post-dosing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 1 diabetes
Treatment for at least 12 months
HbA1c lesser or equal to 11.0%
Body weight between 25 and 80 Kg
Capable to use the device

Exclusion Criteria:

Any diseases other than diabetes requiring prescriptive medication
Known or suspected allergy to trial product or related products
Active proliferative retinopathy as judged by the Investigator
Recurrent severe hypoglycaemia as judged by the Investigator
The receipt of any investigational drug within 4 weeks prior to this trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

17 Years

Standard Ages

Child

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		Glostrup Municipality		2600	Denmark

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1

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