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Observational Study to Evaluate the Safety and Efficacy of NovoMix® 70 in Type 2 Diabetes (INTENSIV)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00704223
First Posted: June 24, 2008
Last Update Posted: June 24, 2014
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 70 under normal clinical practice conditions in Austria.

Condition Intervention
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study on Safety and Efficacy in Subjects Using NovoMix® 70 (Biphasic Insulin Aspart) for Treatment of Type 2 Diabetes Mellitus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • number of major and minor hypoglycaemic events and adverse events [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: 3 months ]
  • PPBG [ Time Frame: 3 months ]
  • FBG [ Time Frame: 3 months ]

Biospecimen Retention:   Samples With DNA
Blood sample

Enrollment: 619
Study Start Date: May 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: biphasic insulin aspart
Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation
Other Name: NovoMix® 70

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male and female above 18 years with type 2 diabetes
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • HbA1c over 7%
  • No contraindication with NovoMix® 70

Exclusion Criteria:

  • Type 1 diabetes
  • Subjects participating in a clinical trial or another observational study
  • Subjects under previous basis-bolus insulin therapy
  • Women who are pregnant, breast feeding and women of child bearing capacity who are not using any reliable contraceptive method
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00704223


Locations
Austria
Wien, Austria, 1140
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00704223     History of Changes
Other Study ID Numbers: BIASP-3576
First Submitted: June 20, 2008
First Posted: June 24, 2008
Last Update Posted: June 24, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin Aspart
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs