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
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 April 17, 2014