Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00704223
First received: June 20, 2008
Last updated: June 15, 2012
Last verified: September 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • number of major and minor hypoglycaemic events and adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • PPBG [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • FBG [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood sample


Enrollment: 590
Study Start Date: May 2008
Study Completion Date: October 2008
Primary Completion Date: October 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704223

Locations
Austria
Wien, Austria, 1140
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Angelika Duarte, MD Novo Nordisk Pharma GmbH Austria
  More Information

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

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00704223     History of Changes
Other Study ID Numbers: BIASP-3576
Study First Received: June 20, 2008
Last Updated: June 15, 2012
Health Authority: Austria: Not required for observational study in Austria

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

ClinicalTrials.gov processed this record on May 21, 2013