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

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ClinicalTrials.gov Identifier: NCT00704223
Recruitment Status : Completed
First Posted : June 24, 2008
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart

Study Type : Observational
Actual Enrollment : 619 participants
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
Study Start Date : May 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




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

Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 3 months ]
  2. PPBG [ Time Frame: 3 months ]
  3. FBG [ Time Frame: 3 months ]

Biospecimen Retention:   Samples With DNA
Blood sample


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00704223     History of Changes
Other Study ID Numbers: BIASP-3576
First Posted: June 24, 2008    Key Record Dates
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