NCT00675220

Brief Summary

This study is conducted in Asia. The aim of this observational study is to collect efficacy and safety data in diabetic patients with acute hyperglycemia using NovoRapid™ FlexPen™ as per normal clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
373

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

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

June 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2008

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

6 months

First QC Date

May 6, 2008

Last Update Submit

October 26, 2016

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Delivery Systems

Outcome Measures

Primary Outcomes (1)

  • Safety profile of Insulin Aspart among Filipino patients

    1-month follow-up for outpatients; 1 month or upon discharge for inpatients whichever comes first

Study Arms (1)

A

Drug: insulin aspart

Interventions

insulin aspartDRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Diabetes

You may qualify if:

  • Patients with diabetes mellitus (according to product labelling)

You may not qualify if:

  • Hypoglycaemia
  • Hypersensitivity to insulin aspart or to any of the excipients (according to product labelling)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Manila, 1605, Philippines

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic 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

May 6, 2008

First Posted

May 9, 2008

Study Start

June 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

PH(1)