An Observational Study to Assess Safety and Effectiveness... | NCT00700648

Studies
An Observational Study to Assess Safety and Effectiveness of Intravenous NovoRapid® in Hospitalised Subjects

NCT00700648

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jan 4, 2017Estimated

Enrollment

3,024Actual

Phase

Not provided

Conditions

Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2

Interventions

insulin aspart

Countries

India

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

Jan 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

Mar 2008

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Jun 18, 2008

First Submission Date that Met QC Criteria

Jun 18, 2008

First Posted Date

Jun 19, 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

Jan 2, 2017

Last Update Posted Date

Jan 4, 2017Estimated

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 observational study is to evaluate the side effects profile and benefits of using intravenous insulin aspart infusion in hospitalised subjects under normal clinical practice conditions in India.

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

3,024Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A			Drug: insulin aspart

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin aspart	Drug	Intravenous NovoRapid dose & frequency as decided by treating physician	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of AEs (adverse event)		After 6 months
Incidence of SAEs (serious adverse event)		After 6 months

Secondary Outcomes

Measure	Description	Time Frame
Other safety & efficacy measures		After 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any hospitalized subject with hyperglycaemia requiring intravenous insulin therapy is eligible for the study based on the discretion of the physician.

Exclusion Criteria:

Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude;
Subjects with a hypersensitivity to NovoRapid or to any of the excipients.
Subjects with conditions considered as contraindications.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Hospitalized subjects requiring intravenous insulin therapy

Sampling Method

Non-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		Bangalore		560001	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	Intravenous insulin aspart in a hospital setting: results from an observational study examining patient outcomes and physician preferences; Udwadia F, Bhattacharyya A, Seshiah V et al.; Diabetes Manage. (2012) 2(2), 103-110

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

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

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