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

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

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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
Investigators
Study Director: Corporate Vice President for diabetes and devices Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

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 May 19, 2013