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

October 27, 2016 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55127
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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®

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: insulin detemir
Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany
Other Names:
  • Levemir®
B
Drug: isophane human insulin
Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
diabetes-related quality of life (ADDQoL)
Time Frame: over whole study duration, 24 weeks per patient
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
over whole study duration, 24 weeks per patient
Body weight
Time Frame: over whole study duration, 24 weeks per patient
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
over whole study duration, 24 weeks per patient
Insulin dose
Time Frame: over whole study duration, 24 weeks per patient
over whole study duration, 24 weeks per patient
concomitant diabetes therapy (OADs)
Time Frame: over whole study duration, 24 weeks per patient
over whole study duration, 24 weeks per patient
Hypoglycemia
Time Frame: over whole study duration, 24 weeks per patient
over whole study duration, 24 weeks per patient
Adverse drug reactions, ADR
Time Frame: over whole study duration, 24 weeks per patient
over whole study duration, 24 weeks per patient
Serious adverse drug reactions, SADR
Time Frame: over whole study duration, 24 weeks per patient
over whole study duration, 24 weeks per patient
Pregnancy
Time Frame: over whole study duration, 24 weeks per patient
over whole study duration, 24 weeks per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

April 22, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 24, 2008

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1951

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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