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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00665808
First received: April 22, 2008
Last updated: October 27, 2016
Last verified: October 2016
  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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665808

Locations
Germany
Novo Nordisk Investigational Site
Mainz, Germany, 55127
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: 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: October 27, 2016
Health Authority: Germany: BfArM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016