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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

Tracking Information
First Submitted Date February 16, 2012
First Posted Date February 22, 2012
Last Update Posted Date January 9, 2017
Study Start Date January 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 16, 2012)
HbA1c (glycosylated haemoglobin)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01536639 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 16, 2012)
  • Fasting plasma glucose (FPG)
  • Post−prandial glucose (PPG)
  • Weight
  • Hypoglycaemia
  • Adverse events
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Physiological Concept of Insulin Therapy in Subjects With Type 2 Diabetes
Official Title Physiological Concept of Insulin Therapy in Subjects With Type 2 Diabetes
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention 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
Study Groups/Cohorts BIAsp 30 users
Intervention: Drug: biphasic insulin aspart 30
Publications * 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 16, 2012)
454
Original Actual Enrollment Same as current
Actual Study Completion Date December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects with type 2 diabetes
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01536639
Other Study ID Numbers BIASP-1929
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date January 2017