Observational Study of Type 2 Diabetes Patients Failing o... | NCT00658099

Studies
Observational Study of Type 2 Diabetes Patients Failing on Oral Anti-diabetic Agents Initiated on Levemir® or Insulatard®

NCT00658099

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jan 31, 2017Estimated

Enrollment

699Actual

Phase

Not provided

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

insulin detemir
insulin NPH

Countries

Romania

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

Nov 2007

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Apr 8, 2008

First Submission Date that Met QC Criteria

Apr 11, 2008

First Posted Date

Apr 14, 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 30, 2017

Last Update Posted Date

Jan 31, 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 change in weight in type 2 diabetes patients using Levemir® or Insulatard® 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

699Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A			Drug: insulin detemir
B			Drug: insulin NPH

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in weight		after 6 months of treatment

Secondary Outcomes

Measure	Description	Time Frame
The effect on metabolic control assessed by the changes in glycaemic parameters: HbA1c and blood glucose values		after 6 months of treatment
The incidence of hypoglycaemic events		after 6 months of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes
HbA1c greater than 7.0% and/or hypoglycaemia
variable FBG and/or weight increase
the selection of the subjects will be at the discretion of the participating physician

Exclusion Criteria:

non-type 2 diabetes
current treatment with Levemir® or Insulatard®
hypersensitivity to Levemir® or Insulatard® or to any of the excipients
women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 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

Type 2 diabetes patiens failing on oral anti-diabetic agents

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		Bucharest		010031	Romania

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	Doina Catrinoiu; Effect of Once-Daily Detemir vs NPH Insulin on Body Weight and Metabolic Control When Added to OADs in Type 2 Diabetes; 2029-PO; 69th Scientific Sessions (2009); American Diabetes Association

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

ID	Term
D000069057	Insulin Detemir
D007336	Insulin, Isophane

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

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2