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

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: isophane human insulin; Drug: insulin detemir

• Registration Number: NCT00665808
• Lead Sponsor: Novo Nordisk A/S

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 available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-04-22
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-24
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B	isophane human insulin	-
A	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
treatment satisfaction (DTSQs and DTSQc)	over whole study duration, 24 weeks per patient

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Mainz, Germany