Safety of Treatment Initiation With Biphasic Insulin Aspa... | NCT01565733

Studies
Safety of Treatment Initiation With Biphasic Insulin Aspart 30 in Hospitalised Patients With Type 2 Diabetes

NCT01565733

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Oct 31, 2016Estimated

Enrollment

2,223Actual

Phase

Not provided

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 30

Countries

Poland

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

Jan 2007

Primary Completion Date

Jul 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

Mar 26, 2012

First Submission Date that Met QC Criteria

Mar 26, 2012

First Posted Date

Mar 29, 2012Estimated

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 27, 2016

Last Update Posted Date

Oct 31, 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 Europe. The aim of this study is to evaluate the safety and efficacy of biphasic insulin aspart (NovoMix® 30) in hospitalised patients with type 2 diabetes with the aim of intensifying their treatment.

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

2,223Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NovoMix® 30 users			Drug: biphasic insulin aspart 30

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biphasic insulin aspart 30	Drug	Biphasic insulin aspart 30 prescribed solely on the basis of clinical judgement. Initial dose, frequency of injections and further dosage amendments at the discretion of the treating physician.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of severe hypoglycaemic episodes

Secondary Outcomes

Measure	Description	Time Frame
Number of severe hypoglycaemic episodes
Number of mild hypoglycaemic episodes
Postprandial glucose concentration after breakfast, lunch, and dinner

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with type 2 diabetes
Treated with oral anti-diabetics and/or human insulin

Exclusion Criteria:

Persons previously included in the trial
Hypersensitive to biphasic insulin aspart or any of the excipients
Pregnant or lactating women, or those who plan to get pregnant within the next 12 months

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

Patients with type 2 diabetes requiring treatment with NovoMix® 30 insulin on admission who before hospitalisation had been treated with oral antidiabetics and/or human insulin

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		Warsaw		PL-02-274	Poland

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
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
C557564	insulin aspart, insulin aspart protamine drug combination 30:70

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided