NovoLet® Acceptance Study Within the Hospital Practise in... | NCT01492205

Studies
NovoLet® Acceptance Study Within the Hospital Practise in Indonesia

NCT01492205

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Oct 14, 2016Estimated

Enrollment

203Actual

Phase

Not provided

Conditions

Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2

Interventions

insulin human

Countries

Indonesia

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

Oct 2016

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

Sep 2005

Primary Completion Date

Jun 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Dec 12, 2011

First Submission Date that Met QC Criteria

Dec 12, 2011

First Posted Date

Dec 14, 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

Oct 13, 2016

Last Update Posted Date

Oct 14, 2016Estimated

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 study is conducted in Asia. The aim of this study is to evaluate the overall acceptance of healthcare professionals (nurses and doctors) to the NovoLet® system used in a hospital environment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

203Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Human insulin			Drug: insulin human

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin human	Drug	All subjects were treated with human insulin administered either by using the NovoLet® pre-filled insulin system or the conventional vial and syringe method. Doctors and nurses must personally administer at least 10 insulin doses to each patient under their individual clinical supervision for assessment of the NovoLet® pre-filled insulin system

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall acceptance of the NovoLet® system among healthcare professionals (nurses and doctors)

Secondary Outcomes

Measure	Description	Time Frame
Time taken for the healthcare professionals (nurses and doctors) to teach the patient
Incidence of adverse drug reactions

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 1 diabetes
Type 2 diabetes
Likely to be hospitalised and require insulin therapy

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

Individuals with either type 1 or type 2 diabetes, who were likely to be hospitalised and require insulin therapy in Indonesia

Sampling Method

Probability Sample

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		Jakarta		12520	Indonesia

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1
D003924	Diabetes Mellitus, Type 2

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