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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01492218
First received: December 12, 2011
Last updated: April 11, 2012
Last verified: April 2012

December 12, 2011
April 11, 2012
March 2004
August 2004   (final data collection date for primary outcome measure)
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01492218 on ClinicalTrials.gov Archive Site
  • Adverse events [ Designated as safety issue: No ]
  • Technical complaints of NovoLet® device [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study With Mixtard® 30 NovoLet® to Assess Patient Satisfaction
A Prospective, Open-labelled, Non-controlled Observational Study to Assess Patient Satisfaction, Physician Acceptability and Safety of Mixtard® 30 NovoLet® for the Treatment of Diabetes Mellitus

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
Drug: biphasic 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.
NovoLet®
Intervention: Drug: biphasic human insulin 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1330
August 2004
August 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diabetes mellitus (type 1 or type 2)
  • Patient not presently using Mixtard® 30 NovoLet®
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT01492218
NOPEN3-1885
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Corporate Vice President for diabetes and devices Novo Nordisk A/S
Novo Nordisk A/S
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP