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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.
 
ClinicalTrials.gov Identifier: NCT01536639
Recruitment Status : Completed
First Posted : February 22, 2012
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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

Study Design
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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


Groups and Cohorts
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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


Outcome Measures
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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

Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Subjects with type 2 diabetes
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01536639


Locations
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Slovakia
Novo Nordisk Investigational Site
Bratislava, Slovakia, 811 05
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov 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:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin Aspart
Biphasic Insulins
Insulin aspart, insulin aspart protamine drug combination 30:70
Hypoglycemic Agents
Physiological Effects of Drugs