NovoLet® Acceptance Study Within the Hospital Practise in Indonesia

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01492205
First received: December 12, 2011
Last updated: April 11, 2012
Last verified: April 2012
  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
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: insulin human

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) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time taken for the healthcare professionals (nurses and doctors) to teach the patient [ Designated as safety issue: No ]
  • Incidence of adverse drug reactions [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01492205

Locations
Indonesia
Jakarta, Indonesia, 12520
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Corporate Vice President for diabetes and devices Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01492205     History of Changes
Other Study ID Numbers: NOPEN3-1887
Study First Received: December 12, 2011
Last Updated: April 11, 2012
Health Authority: Indonesia: National Agency of Drug and Food Control

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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014