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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00665808

First Posted: April 24, 2008

Last Update Posted: October 28, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Novo Nordisk A/S

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


Study Type:	Observational
Study Design:	Time Perspective: 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:

Drug Information available for: Insulin Insulin human Insulin detemir

U.S. FDA Resources

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:

treatment satisfaction (DTSQs and DTSQc) [ Time Frame: over whole study duration, 24 weeks per patient ]

Secondary Outcome Measures:

diabetes-related quality of life (ADDQoL) [ Time Frame: over whole study duration, 24 weeks per patient ]
general health-related quality of life (EQ-5D) [ Time Frame: over whole study duration, 24 weeks per patient ]
Body weight [ Time Frame: over whole study duration, 24 weeks per patient ]
metabolic control (HbA1c, fasting morning blood glucose) [ Time Frame: over whole study duration, 24 weeks per patient ]
Insulin dose [ Time Frame: over whole study duration, 24 weeks per patient ]
concomitant diabetes therapy (OADs) [ Time Frame: over whole study duration, 24 weeks per patient ]
Hypoglycemia [ Time Frame: over whole study duration, 24 weeks per patient ]
Adverse drug reactions, ADR [ Time Frame: over whole study duration, 24 weeks per patient ]
Serious adverse drug reactions, SADR [ Time Frame: over whole study duration, 24 weeks per patient ]
Pregnancy [ Time Frame: over whole study duration, 24 weeks per patient ]


Enrollment:	8125
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 Other Name: Levemir®
B	Drug: isophane human insulin Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665808

Locations


Germany
Novo Nordisk Investigational Site
Mainz, Germany, 55127

Sponsors and Collaborators

Novo Nordisk A/S

Investigators


Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S

More Information

Additional Information:

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


Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00665808 History of Changes
Other Study ID Numbers:	NN304-1951
First Submitted:	April 22, 2008
First Posted:	April 24, 2008
Last Update Posted:	October 28, 2016
Last Verified:	October 2016

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin, Globin Zinc Isophane insulin, beef	Insulin Insulin Detemir Isophane Insulin, Human Insulin, Isophane Hypoglycemic Agents Physiological Effects of Drugs

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