NCT01492205

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

December 12, 2011

Last Update Submit

October 13, 2016

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • Time taken for the healthcare professionals (nurses and doctors) to teach the patient

  • Incidence of adverse drug reactions

Study Arms (1)

Human insulin

Drug: insulin human

Interventions

insulin humanDRUG

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

Human insulin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals with either type 1 or type 2 diabetes, who were likely to be hospitalised and require insulin therapy in Indonesia

You may qualify if:

  • Type 1 diabetes
  • Type 2 diabetes
  • Likely to be hospitalised and require insulin therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Jakarta, 12520, Indonesia

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 14, 2011

Study Start

September 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

October 14, 2016

Record last verified: 2016-10

Locations

ID(1)