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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01492218
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : February 28, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: biphasic human insulin 30

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Study Type : Observational
Actual Enrollment : 1330 participants
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
Actual Study Start Date : March 15, 2004
Actual Primary Completion Date : August 30, 2004
Actual Study Completion Date : August 30, 2004

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score

Secondary Outcome Measures :
  1. Adverse events
  2. Technical complaints of NovoLet® device

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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®

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01492218

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Novo Nordisk Investigational Site
Manilla, Philippines, 1605
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR,1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S Identifier: NCT01492218     History of Changes
Other Study ID Numbers: NOPEN3-1885
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin, pork; isophane insulin, pork drug combination 30:70
Hypoglycemic Agents
Physiological Effects of Drugs