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
  Purpose

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.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: biphasic human insulin 30

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Designated as safety issue: No ]
  • Technical complaints of NovoLet® device [ Designated as safety issue: No ]

Enrollment: 1330
Study Start Date: March 2004
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NovoLet® 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.

  Eligibility

Genders Eligible for Study:   Both
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®

Criteria

Inclusion Criteria:

  • Diabetes mellitus (type 1 or type 2)
  • Patient not presently using Mixtard® 30 NovoLet®
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492218

Locations
Philippines
Manilla, Philippines, 1605
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Corporate Vice President for diabetes and devices Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01492218     History of Changes
Other Study ID Numbers: NOPEN3-1885
Study First Received: December 12, 2011
Last Updated: April 11, 2012
Health Authority: Philippines: Bureau of Food and Drugs

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014