Observational Study to Observe the Efficacy of Levemir® (Insulin Detemir) in Patients With Type 2 Diabetes.

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00793273
First received: November 18, 2008
Last updated: June 28, 2012
Last verified: April 2012
  Purpose

This study is conducted in Europe. The aim of this observational study is to observe the efficacy of Levemir® treatment in patients with type 2 diabetes in everyday clinical practice in Switzerland. Furthermore the time period between diagnosis of type 2 diabetes and insulin initiation is evaluated.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin detemir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Glycaemic Control After Initiation of Levemir® in Patients With Type 2 Diabetes Mellitus and Time Period Between Diagnosis of Type 2 Diabetes Mellitus and Insulin Initiation.

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in HbA1c of treatment [ Time Frame: after 12 to 16 weeks ] [ Designated as safety issue: No ]
  • Change in FPG (fasting plasma glucose) of treatment [ Time Frame: after 12 to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of adverse events [ Time Frame: after 12 to 16 weeks ] [ Designated as safety issue: No ]
  • Insulin dose and concomitant oral antidiabetic medication time period between diagnosis of type 2 diabetes and insulin initiation [ Time Frame: after 12 to 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 1072
Study Start Date: November 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin detemir
Effectiveness and safety data collection in connection with the use of the drug Levemir® in daily clinical practice
Other Names:
  • Levemir®
  • NN304

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients from general practice setting who have been deemed appropriate to receive Levemir® as part of routine out-patient care by the prescribing physician.

Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus
  • Insulin-naive or currently treated with another basal insulin
  • Inclusion of patients at the discretion of the treating physician after the decision to prescribe Levemir®

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Patients treated with short acting or with premix insulin
  • Women who are pregnant, breast feeding or have the intention to become pregnant
  • Known or suspected allergy to the study product or related product
  • Any exclusion criteria according to the Swiss Levemir® SPC (Summary of Product Characteristics)
  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: NCT00793273

Locations
Switzerland
Zurich, Oerlikon, Switzerland, CH-8050
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Susanne Landolt, MSc.pharm Novo Nordisk Pharma AG
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00793273     History of Changes
Other Study ID Numbers: NN304-3694
Study First Received: November 18, 2008
Last Updated: June 28, 2012
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on July 23, 2014