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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00665808
First received: April 22, 2008
Last updated: June 26, 2012
Last verified: June 2012
  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:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • diabetes-related quality of life (ADDQoL) [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
  • general health-related quality of life (EQ-5D) [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
  • metabolic control (HbA1c, fasting morning blood glucose) [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
  • Insulin dose [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
  • concomitant diabetes therapy (OADs) [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
  • Hypoglycemia [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: Yes ]
  • Adverse drug reactions, ADR [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: Yes ]
  • Serious adverse drug reactions, SADR [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: Yes ]
  • Pregnancy [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665808

Locations
Germany
Mainz, Germany, 55127
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Martin Grundner Novo Nordisk Pharma GmbH
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00665808     History of Changes
Other Study ID Numbers: NN304-1951
Study First Received: April 22, 2008
Last Updated: June 26, 2012
Health Authority: Germany: BfArM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Insulin, NPH
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014