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Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: September 18, 2008
Last updated: October 27, 2016
Last verified: October 2016
This study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective is also to observe the different regimes of starting and maintaining the treatment with NovoMix® 50 during one year.

Condition Intervention
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 50

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicentre, Open Label, Un-controlled , Observational, 12-month Study in Subjects Using: NovoMix® 50 (Biphasic Insulin Aspart 50) for Treatment of Type 2 Diabetes Mellitus in Slovenia

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: At 0, 3, 6, 9, 12 months ]

Secondary Outcome Measures:
  • Percentage of subjects achieving target HbA1c [ Time Frame: At 0, 3, 6, 9, 12 months ]
  • Change in FPG (fasting plasma glucose) [ Time Frame: At 0, 3, 6, 9, 12 months ]
  • Change in PPG (postprandial glucose) [ Time Frame: At 0, 3, 6, 9, 12 months ]
  • Change in number of hypoglycaemic events [ Time Frame: At 0, 3, 6, 9, 12 months ]
  • Change in insulin presentation [ Time Frame: At 0, 3, 6, 9, 12 months ]
  • Dose and number of injections [ Time Frame: At 0, 3, 6, 9, 12 months ]
  • Number of ADRs (adverse drug reaction) [ Time Frame: At 0, 3, 6, 9, 12 months ]

Enrollment: 270
Study Start Date: September 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: biphasic insulin aspart 50
Efficacy and safety data collection in connection with the use of the drug NovoMix® 50 in daily clinical practice.
Other Name: NovoMix® 50


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetes patients from both general and speciality practice settings who have been deemed appropriate to receive NovoMix® 50 as new treatment and as part of routine out-patient care by the prescribing physician.

Inclusion Criteria:

  • Type 2 diabetes treated with biphasic human insulin with or without metformin
  • Inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the physician's opinion, benefit from treatment with NovoMix® 50

Exclusion Criteria:

  • Subjects with diagnosed type 1 diabetes mellitus
  • Subjects treated with short acting or intermediate acting human insulin or any insulin analogue
  • Subjects who are unlikely to comply with study description, e.g. uncooperative attitude, inability to come for regular visits
  • Subjects with a hypersensitivity to biphasic insulin aspart 50 (NovoMix® 50 )or to any of the excipients
  • Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 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 identifier: NCT00755833

Novo Nordisk Investigational Site
Ljubljana, Slovenia, SI-1000
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 Identifier: NCT00755833     History of Changes
Other Study ID Numbers: BIASP-3674
Study First Received: September 18, 2008
Last Updated: October 27, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Aspart
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on August 21, 2017