Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-Life" Usage in Germany - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00665808

Purpose

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.

Condition	Intervention
Diabetes Mellitus, Type 2	Drug: insulin detemir Drug: isophane human insulin

Study Type:	Observational
Study Design:	Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin Detemir

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	12000
Study Start Date:	October 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: insulin detemir Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany
B	Drug: isophane human insulin Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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®

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665808

Locations

Germany

Mainz, Germany, 55127

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Martin Grundner

Novo Nordisk Pharma GmbH

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-1951
Study First Received:	April 22, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00665808 History of Changes
Health Authority:	Germany: BfArM

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Quality of Life

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on July 02, 2009