Observational Study of Patients Using NovoMix® 30 or Leve... | NCT00665093

Studies
Observational Study of Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes

NCT00665093

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jan 9, 2017Estimated

Enrollment

1,569Actual

Phase

Not provided

Conditions

Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 30
insulin detemir

Countries

North Macedonia

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

May 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

Apr 22, 2008

First Submission Date that Met QC Criteria

Apr 22, 2008

First Posted Date

Apr 23, 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 trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® 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

1,569Actual

Arms/Interventions Module

Arm Groups

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

Interventions

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

Measure	Description	Time Frame
HbA1c		at 24 weeks

Measure	Description	Time Frame
FPG, PG profile, weight, % of subjects on target		at 24 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Levemir® above 6 yrs
NovoMix® 30 above 18 yrs
Patients with Type 1 or Type 2 diabetes, including newly diagnosed

Exclusion Criteria:

Current treatment with NovoMix® 30 or Levemir®

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 1 and Type 2 diabetes mellitus

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		Skopje		MK-1000	North Macedonia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	Milenkovic T. Significant Improvements in Glycemic Control with BIAsp 30 in Clinical Reality: Experience from clinical practice in Macedonia. ADA American Diabetes Association 2009; Country: USA City: New Orleans

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

ID	Term
C557564	insulin aspart, insulin aspart protamine drug combination 30:70
D000069057	Insulin Detemir

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

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