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Prandial Orientated Biphasic Insulin Aspart 30 Therapy - the Physiological Premix Insulin Therapy for Type 2 Diabetes (ProMix)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01536652
First Posted: February 22, 2012
Last Update Posted: March 7, 2016
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
February 16, 2012
February 22, 2012
March 7, 2016
January 2006
November 2006   (Final data collection date for primary outcome measure)
HbA1c (glycosylated haemoglobin)
Same as current
Complete list of historical versions of study NCT01536652 on ClinicalTrials.gov Archive Site
  • Body weight
  • Preprandial and postprandial blood glucose values (self measured)
  • Insulin dosage
  • Incidence of (serious) adverse drug reactions
  • Incidence of hypoglycaemic episodes
Same as current
Not Provided
Not Provided
 
Prandial Orientated Biphasic Insulin Aspart 30 Therapy - the Physiological Premix Insulin Therapy for Type 2 Diabetes
Prandial Oriented NovoMix 30® - the Physiological Insulin Therapy of Diabetes Type 2
This study is conducted in Europe. The aim of this observational study is to document the glycaemic parameters, adverse events, including drug reactions, as well as hypoglycaemic episodes, in patients that switched from insulin glargine combined with oral antidiabetic drugs (OADs) to biphasic insulin aspart 30 (NovoMix® 30) combined with OADs, when applicable.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Any patient with diabetes mellitus type 2, using insulin glargine in combination with one or more OADs, being in inadequate glycaemic control and are indicated to receive biphasic insulin aspart 30
  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30
Prescription at the discretion of the treating physician
BIAsp 30 users
Intervention: Drug: biphasic insulin aspart 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4994
November 2006
November 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with diabetes mellitus type 2
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01536652
BIASP-1932
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
March 2016