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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:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01536652
First received: February 16, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted

February 16, 2012
February 16, 2012
January 2006
November 2006   (final data collection date for primary outcome measure)
HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Body weight [ Designated as safety issue: No ]
  • Preprandial and postprandial blood glucose values (self measured) [ Designated as safety issue: No ]
  • Insulin dosage [ Designated as safety issue: No ]
  • Incidence of (serious) adverse drug reactions [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01536652
BIASP-1932
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Lars Winkler Novo Nordisk Pharma GmbH
Novo Nordisk A/S
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP