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CompletedNCT01492218Updated Feb 28, 2017

Observational Study With Mixtard® 30 NovoLet® to Assess Patient Satisfaction

An observational study in Diabetes, Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Philippines. Per ClinicalTrials.gov, last updated 2017-02-28.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,330
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 1,330 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Eligibility criteria

Inclusion Criteria:

  • Diabetes mellitus (type 1 or type 2)
  • Patient not presently using Mixtard® 30 NovoLet®
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,330 participants (actual)
Patient registry
No

Groups and cohorts

  • NovoLet®

    Drug: biphasic human insulin 30

Interventions

  • Drugbiphasic human insulin 30

    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.

06

What researchers measure

Primary outcomes

  1. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score

Secondary outcomes

  1. Adverse events

  2. Technical complaints of NovoLet® device

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Manilla, 1605, Philippines
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01492218
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Dec 14, 2011
Start date
Mar 15, 2004
Primary completion
Aug 30, 2004
Completion
Aug 30, 2004
Last update
Feb 28, 2017

Study contacts

Global Clinical Registry (GCR,1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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