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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: December 5, 2011
Last updated: February 18, 2016
Last verified: February 2016
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 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


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

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

Lund, Sweden, 221 85
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
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: February 18, 2016
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Biphasic Insulins
Insulin Aspart
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Isophane
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 01, 2016