Observational Study on Treatment Satisfaction of Levemir®... | NCT00665808

Studies
Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-life" Usage in Germany

NCT00665808

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Oct 28, 2016Estimated

Enrollment

8,125Actual

Phase

Not provided

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

insulin detemir
isophane human insulin

Countries

Germany

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

Official Title

Insulin Detemir (Levemir®) Versus Isophane (NPH) Insulin (Protaphane®) in Combination With Oral Antidiabetic Agents (OAD) in Patients With Diabetes Mellitus Type 2 Comparing Treatment Satisfaction, Diabetes-related and General Health-related Quality of Life, as Well as Diabetes-control

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

Oct 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Apr 22, 2008

First Submission Date that Met QC Criteria

Apr 23, 2008

First Posted Date

Apr 24, 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

Oct 27, 2016

Last Update Posted Date

Oct 28, 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 NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when using Levemir® versus Protaphane® in combination with OADs in daily settings.

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

8,125Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A			Drug: insulin detemir
B			Drug: isophane human insulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin detemir	Drug	Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
treatment satisfaction (DTSQs and DTSQc)		over whole study duration, 24 weeks per patient

Secondary Outcomes

Measure	Description	Time Frame
diabetes-related quality of life (ADDQoL)		over whole study duration, 24 weeks per patient
general health-related quality of life (EQ-5D)		over whole study duration, 24 weeks per patient

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent obtained from patient before first documentation of treatment in the observational study.
Type 2 diabetes mellitus
Patients, who should intensify treatment with long acting insulin in addition to their treatment with oral antidiabetic agents, due to insufficient blood glucose control
No contraindication for use of Protaphane® or Levemir®

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients willing and able to give signed informed consent; Patients with Type 2 diabetes mellitus; Patients, who should intensify treatment with long acting insulin in addition to their treatment with oral antidiabetic agents, due to insufficient blood glucose control; Patients with no regular use of short acting insulin (occasional use for correction is allowed); Patients with no contraindication for use of Protaphane® or Levemir®

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		Mainz		55127	Germany

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
D000069057	Insulin Detemir
D007336	Insulin, Isophane

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided