Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Physiological Concept of Insulin Therapy in Subjects With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01536639
Recruitment Status : Completed
First Posted : February 22, 2012
Last Update Posted : January 9, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted in Europe. The aim of the study was to evaluate the safety and efficacy of biphasic insulin aspart 30 (NovoMix® 30) when switching to a modern premix insulin analogue treatment compared to previous insulin regimen in routine clinical practice in the Slovak Republic.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30

Layout table for study information
Study Type : Observational
Actual Enrollment : 454 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physiological Concept of Insulin Therapy in Subjects With Type 2 Diabetes
Study Start Date : January 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
BIAsp 30 users Drug: biphasic insulin aspart 30
Administered by subcutaneous injection. The physician determined the starting dose and frequency, as well as later changes to either dose or frequency, if any

Primary Outcome Measures :
  1. HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures :
  1. Fasting plasma glucose (FPG)
  2. Post−prandial glucose (PPG)
  3. Weight
  4. Hypoglycaemia
  5. Adverse events

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with type 2 diabetes in whom at the discretion of the investigator it was decided to change insulin regimen to biphasic insulin aspart 30

Inclusion Criteria:

  • Subjects with type 2 diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01536639

Layout table for location information
Novo Nordisk Investigational Site
Bratislava, Slovakia, 811 05
Sponsors and Collaborators
Novo Nordisk A/S
Layout table for investigator information
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Significant reduction in proportion of T2 diabetes patients at high risk for developing late complications after switching human insulin to BIAsp 30; results of an observational study in Slovakia; Z. Schroner; 2085-PO; 69th American Diabetes Association, New Orleans 2009

Layout table for additonal information
Responsible Party: Novo Nordisk A/S Identifier: NCT01536639    
Other Study ID Numbers: BIASP-1929
First Posted: February 22, 2012    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Aspart
Biphasic Insulins
Insulin aspart, insulin aspart protamine drug combination 30:70
Hypoglycemic Agents
Physiological Effects of Drugs