An Observational Study of Type 2 Diabetes in Patients Sta... | NCT00696995

Studies
An Observational Study of Type 2 Diabetes in Patients Starting on NovoMix® 30 Treatment

NCT00696995

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jan 9, 2017Estimated

Enrollment

509Actual

Phase

Not provided

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 30

Countries

Finland

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

Jan 2007

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Jun 11, 2008

First Submission Date that Met QC Criteria

Jun 11, 2008

First Posted Date

Jun 13, 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 6, 2017

Last Update Posted Date

Jan 9, 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 Europe. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions when initiating or switching to insulin therapy with NovoMix® 30 in subjects with type 2 diabetes 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

Retention

Enrollment

509Actual

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 as well as dose alterations to be determined by the physician according to normal clinical evaluation	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of serious adverse drug reactions, including major hypoglycaemic events		at 26 weeks

Secondary Outcomes

Measure	Description	Time Frame
The number of all hypoglycaemic events		at 26 weeks
HbA1c		at 12 weeks and 26 weeks
Fasting plasma glucose at visits

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Type 2 diabetes
Insulin-naive or previously treated by basal only insulin therapy

Exclusion Criteria:

Patients who are unlikely to comply with the protocol
Pregnancy or breastfeeding or intention of becoming pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

99 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with type 2 diabetes.

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		Lahti		15110	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22078072	Result	Makela JK, Schmuser C, Askonen K, Saukkonen T. Starting or switching to biphasic insulin aspart 30 (BIAsp 30) in type 2 diabetes: a multicenter, observational, primary care study conducted in Finland. Diabetes Res Clin Pract. 2012 Jan;95(1):10-8. doi: 10.1016/j.diabres.2011.06.006. Epub 2011 Nov 9.

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

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2