Observational Study of Safety of NovoMix® 30 Treatment for Type 2 Diabetes (Start)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01486875
First received: December 5, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.


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: NovoMix® Start - A Multicentre, Open Label, Non-randomised, Non-interventional, Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix 30® Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of serious adverse drug reactions (SADRs) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Incidence of major hypoglycaemic events [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of all hypoglycaemic events [ Time Frame: In the 4 weeks prior to week 12 and week 26, respectively ] [ Designated as safety issue: No ]
  • HbA1c (glycosylated haemoglobin A1c) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose (FPG) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

Enrollment: 1155
Study Start Date: January 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
BIAsp 30 Drug: biphasic insulin aspart 30
Dose individually adjusted, and administered subcutaneously (under the skin) once or twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

After the physician has decided to initiate biphasic insulin aspart 30 therapy, any insulin-naïve patient with type 2 diabetes mellitus in need of improved metabolic control, as judged by the treating physician, will be able to participate

Criteria

Inclusion Criteria:

  • Subjects with type 2 diabetes
  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: NCT01486875

Locations
Sweden
Lund, Sweden, 221 85
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Kerstin Magnusson Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01486875     History of Changes
Other Study ID Numbers: BIASP-1721
Study First Received: December 5, 2011
Last Updated: December 5, 2011
Health Authority: 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 aspart protamine drug combination 30:70
Insulin, Isophane
Biphasic Insulins
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014