Observational Study to Observe the Safety of NovoMix® 30 Treatment in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00729898
First received: August 5, 2008
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

This study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in patients with type 2 diabetes during NovoMix® 30 treatment.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety of NovoMix® 30 (Biphasic Insulin Aspart) Treatment in Patients With Type 2 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of serious adverse drug reactions, including major hypoglycaemic events [ Time Frame: after 12 and 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of all hypoglycaemic events [ Time Frame: in the 4 weeks preceding visit, at 12 weeks and the final visit at 26 weeks ] [ Designated as safety issue: No ]
  • Number of all adverse drug reactions [ Time Frame: after 12 and 26 weeks ] [ Designated as safety issue: Yes ]
  • HbA1c [ Time Frame: at 12 and 26 weeks ] [ Designated as safety issue: No ]
  • Variability in fasting plasma glucose (FPG) values and average FPG levels [ Time Frame: at visits at 12 and 26 weeks ] [ Designated as safety issue: No ]
  • Weight changes [ Time Frame: at visits at 12 and 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 272
Study Start Date: March 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: biphasic insulin aspart 30
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Name: NovoMix® 30

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study population type 2 diabetes strated on NovoMix® 30

Criteria

Inclusion Criteria:

  • Any patient with diabetes type 2 diabetes
  • Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin
  • Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient

Exclusion Criteria:

  • Known or suspected allergy to study product(s) or related products
  • Pregnancy, breast-feeding or intention of becoming pregnant within the next 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729898

Locations
Denmark
Copenhagen S, Denmark, 2300
Norway
Rud, Norway, 1309
Sweden
Farsta, Sweden, 123 47
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Mattias Haglund Novo Nordisk Scandinavia AB
Study Director: Jakob Larsen Novo Nordisk Scandinavia AB
Study Director: Erik Christiansen, medical manager Novo Nordisk Scandinavia AB
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00729898     History of Changes
Other Study ID Numbers: BIASP-3512
Study First Received: August 5, 2008
Last Updated: June 5, 2012
Health Authority: Denmark: Danish Medicines Agency
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on July 20, 2014