NCT01492218

Brief Summary

This study is conducted in Asia. The aim of this study is to assess patient satisfaction after switching to biphasic human insulin 30 treatment using the NovoLet® insulin device as treatment for diabetes mellitus under normal clinical practice setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 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

March 15, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2004

Completed
7.3 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

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

December 12, 2011

Last Update Submit

February 24, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score

Secondary Outcomes (2)

  • Adverse events

  • Technical complaints of NovoLet® device

Study Arms (1)

NovoLet®

Drug: biphasic human insulin 30

Interventions

biphasic human insulin 30DRUG

Administered via the NovoLet® device and according to the instructions in the product insert or as instructed by the physician. Individually adjusted dosage as instructed by the physician.

NovoLet®

Eligibility Criteria

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

Patients diagnosed with type 1 or type 2 diabetes mellitus and are not presently using Mixtard® 30 NovoLet®

You may qualify if:

  • Diabetes mellitus (type 1 or type 2)
  • Patient not presently using Mixtard® 30 NovoLet®

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

biphasic human insulin 30

Condition Hierarchy (Ancestors)

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

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

March 15, 2004

Primary Completion

August 30, 2004

Study Completion

August 30, 2004

Last Updated

February 28, 2017

Record last verified: 2017-02

Locations

PH(1)