NCT01542060

Brief Summary

This study is conducted in Asia. The aim of this observational study is to collect efficacy and safety data of biphasic insulin aspart (NovoMix® 30) in type 2 diabetes under normal clinical practice conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
298

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

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

January 1, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 1, 2012

Completed
Last Updated

April 12, 2012

Status Verified

April 1, 2012

Enrollment Period

11 months

First QC Date

February 15, 2012

Last Update Submit

April 11, 2012

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c (glycosylated haemoglobin)

Secondary Outcomes (4)

  • FBG (Fasting Blood Glucose)

  • Quality of life assessed through the WHO-DTSQ (World Health Organization-Diabetes Treatment Satisfaction Questionnaire)

  • Incidence of adverse events

  • Incidence of hypoglycaemic episodes

Study Arms (1)

BIAsp 30 users

Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30DRUG

Administered via an insulin injection device. Dosages varied according to individual patients' medical requirement as determined by their attending clinician

BIAsp 30 users

Eligibility Criteria

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

Patients from hospitals or clinics diagnosed with type 2 diabetes mellitus

You may qualify if:

  • Subjects from hospitals or clinics, diagnosed with type 2 diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Amman, 11844, Jordan

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Corporate Vice President for diabetes and devices

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 15, 2012

First Posted

March 1, 2012

Study Start

January 1, 2004

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

April 12, 2012

Record last verified: 2012-04

Locations

JO(1)