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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00665808

Enrollment

8125

Registered

2008-04-24

Start date

2007-10-31

Completion date

2008-12-31

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGinsulin detemir

Observational study on treatment satisfaction of Levemir ® versus Protaphane® during real-life usage in Germany

DRUGisophane human insulin

Observational study on treatment satisfaction of Levemir ® versus Protaphane® during real-life usage in Germany

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
general health-related quality of life (EQ-5D)	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
Insulin dose	over whole study duration, 24 weeks per patient
diabetes-related quality of life (ADDQoL)	over whole study duration, 24 weeks per patient
Hypoglycemia	over whole study duration, 24 weeks per patient
Adverse drug reactions, ADR	over whole study duration, 24 weeks per patient
Serious adverse drug reactions, SADR	over whole study duration, 24 weeks per patient
Pregnancy	over whole study duration, 24 weeks per patient
concomitant diabetes therapy (OADs)	over whole study duration, 24 weeks per patient

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026