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NovoLet® Acceptance Study Within the Hospital Practise in Indonesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01492205
First Posted: December 14, 2011
Last Update Posted: October 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This study is conducted in Asia. The aim of this study is to evaluate the overall acceptance of healthcare professionals (nurses and doctors) to the NovoLet® system used in a hospital environment.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin human Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Doctor and Nurse Survey on Using NovoLet® Within the Hospital Practice in Indonesia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall acceptance of the NovoLet® system among healthcare professionals (nurses and doctors)

Secondary Outcome Measures:
  • Time taken for the healthcare professionals (nurses and doctors) to teach the patient
  • Incidence of adverse drug reactions

Enrollment: 203
Study Start Date: September 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Human insulin Drug: insulin human
All subjects were treated with human insulin administered either by using the NovoLet® pre-filled insulin system or the conventional vial and syringe method. Doctors and nurses must personally administer at least 10 insulin doses to each patient under their individual clinical supervision for assessment of the NovoLet® pre-filled insulin system

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals with either type 1 or type 2 diabetes, who were likely to be hospitalised and require insulin therapy in Indonesia
Criteria

Inclusion Criteria:

  • Type 1 diabetes
  • Type 2 diabetes
  • Likely to be hospitalised and require insulin therapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492205


Locations
Indonesia
Novo Nordisk Investigational Site
Jakarta, Indonesia, 12520
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: NCT01492205     History of Changes
Other Study ID Numbers: NOPEN3-1887
First Submitted: December 12, 2011
First Posted: December 14, 2011
Last Update Posted: October 14, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs