Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-Life" Usage in Germany
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: insulin detemir (Drug); isophane human insulin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Martin Grundner, Study Director, Affiliation: Novo Nordisk Pharma GmbH
Overall contact:
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
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.
Clinical Details
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
Study design: Other, Prospective
Primary outcome: treatment satisfaction (DTSQs and DTSQc)
Secondary outcome: diabetes-related quality of life (ADDQoL)general health-related quality of life (EQ-5D) Body weight metabolic control (HbA1c, fasting morning blood glucose) Insulin dose concomitant diabetes therapy (OADs) Hypoglycemia Adverse drug reactions, ADR Serious adverse drug reactions, SADR Pregnancy
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
Mainz 55127, Germany; Recruiting
Additional Information
Clinical Trials at Novo Nordisk
Starting date: October 2007
Ending date: October 2008
Last updated: April 23, 2008
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