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

Tracking Information

First Received Date ^ICMJE

April 22, 2008

Last Updated Date

November 13, 2009

Start Date ^ICMJE

October 2007

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

treatment satisfaction (DTSQs and DTSQc) [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00665808 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

diabetes-related quality of life (ADDQoL) [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
general health-related quality of life (EQ-5D) [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
Body weight [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
metabolic control (HbA1c, fasting morning blood glucose) [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
Insulin dose [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
concomitant diabetes therapy (OADs) [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
Hypoglycemia [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: Yes ]
Adverse drug reactions, ADR [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: Yes ]
Serious adverse drug reactions, SADR [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: Yes ]
Pregnancy [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Other, Prospective

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: insulin detemir
Drug: isophane human insulin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

8125

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00665808

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study ID Numbers ^ICMJE

NN304-1951

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Martin Grundner

Novo Nordisk Pharma GmbH

Information Provided By

Novo Nordisk

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP