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

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ClinicalTrials.gov Identifier: NCT01536652
Recruitment Status : Completed
First Posted : February 22, 2012
Last Update Posted : March 7, 2016
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

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

Study Type : Observational
Actual Enrollment : 4994 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prandial Oriented NovoMix 30® - the Physiological Insulin Therapy of Diabetes Type 2
Study Start Date : January 2006
Primary Completion Date : November 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
BIAsp 30 users Drug: biphasic insulin aspart 30
Prescription at the discretion of the treating physician

Primary Outcome Measures :
  1. HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures :
  1. Body weight
  2. Preprandial and postprandial blood glucose values (self measured)
  3. Insulin dosage
  4. Incidence of (serious) adverse drug reactions
  5. Incidence of hypoglycaemic episodes

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

Inclusion Criteria:

  • Subjects with diabetes mellitus type 2

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): NCT01536652

Mainz, Germany, 55127
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01536652     History of Changes
Other Study ID Numbers: BIASP-1932
First Posted: February 22, 2012    Key Record Dates
Last Update Posted: March 7, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs