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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
  Purpose
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 Intervention
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prandial Oriented NovoMix 30® - the Physiological Insulin Therapy of Diabetes Type 2

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures:
  • Body weight
  • Preprandial and postprandial blood glucose values (self measured)
  • Insulin dosage
  • Incidence of (serious) adverse drug reactions
  • Incidence of hypoglycaemic episodes

Enrollment: 4994
Study Start Date: January 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
BIAsp 30 users Drug: biphasic insulin aspart 30
Prescription at the discretion of the treating physician

  Eligibility

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
Criteria

Inclusion Criteria:

  • Subjects with diabetes mellitus type 2
  Contacts and Locations
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


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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01536652     History of Changes
Other Study ID Numbers: BIASP-1932
First Submitted: February 16, 2012
First Posted: February 22, 2012
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
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs