Safety and Efficacy of Insulin Aspart in Children With Ty... | NCT01467141

Studies
Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes

NCT01467141

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

26Actual

Phase

Phase 4

Conditions

Diabetes
Diabetes Mellitus, Type 1

Interventions

insulin aspart
human insulin
isophane human insulin

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

Jun 19, 2002Actual

Primary Completion Date

Oct 15, 2003Actual

Completion Date

Oct 15, 2003Actual

First Submitted Date

Nov 4, 2011

First Submission Date that Met QC Criteria

Nov 4, 2011

First Posted Date

Nov 8, 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 23, 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 evaluate safety and efficacy 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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IAsp	Experimental		Drug: insulin aspart Drug: isophane human insulin
HI	Active Comparator		Drug: human insulin Drug: isophane human insulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin aspart	Drug	Injected s.c. (under the skin) three times a day	IAsp

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of hypoglycaemic episodes during the treatment		Week 0; week 24
Change in HbA1c (glycosylated haemoglobin A1c)		Week 0; week 24

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Adverse Events (AEs)		Week 0; week 24

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 1 diabetes
Treatment with insulin for at least 6 months prior to inclusion
HbA1c below or equal to 11.0 %
Currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion

Exclusion Criteria:

The receipt of any investigational drug within one month prior to this trial
Recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator
Total daily insulin doses at least 1.80 IU/kg
Treatment with oral hypoglycaemic agents
Known or suspected allergy to trial product or related products

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

6 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		Berlin		13353	Germany
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17850471	Result	Danne T, Rastam J, Odendahl R, Nake A, Schimmel U, Szczepanski R, Moeller J, Deiss D. Parental preference of prandial insulin aspart compared with preprandial human insulin in a basal-bolus scheme with NPH insulin in a 12-wk crossover study of preschool children with type 1 diabetes. Pediatr Diabetes. 2007 Oct;8(5):278-85. doi: 10.1111/j.1399-5448.2007.00261.x.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D061267	Insulin Aspart
D007328	Insulin
D007336	Insulin, Isophane

ID	Term
D061266	Insulin, Short-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1