Observational Study to Evaluate the Safety of NovoMix® 30... | NCT00709683

Studies
Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®

NCT00709683

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Mar 7, 2016Estimated

Enrollment

216Actual

Phase

Not provided

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 30

Countries

Tunisia

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

Mar 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

May 2008

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Jul 1, 2008

First Submission Date that Met QC Criteria

Jul 1, 2008

First Posted Date

Jul 3, 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

Mar 4, 2016

Last Update Posted Date

Mar 7, 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 Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.

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

216Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A			Drug: biphasic insulin aspart 30

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biphasic insulin aspart 30	Drug	Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of major hypoglycaemic events reported as serious adverse drug reactions		during 26 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Number of serious adverse drug reactions		during 26 weeks of treatment
Number of serious adverse events		during 26 weeks of treatment
Number of all major (daytime and nocturnal) hypoglycaemic events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes having failed on basal insulin with or without OAD
HbA1c greater than 7.0%

Exclusion Criteria:

Subjects being unlikely to comply with protocol requirements
Subjects who previously enrolled in this study
Subjects with hypersensitivity to biphasic insulin aspart or any of the excipients
Women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method

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

Type 2 diabetic patients

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
		Tunisia		1053	Tunisia

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