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
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 April 23, 2014