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Completed

NCT Number: NCT01536652

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Mainz, 55127, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with diabetes mellitus type 2

Treatment and study plan

biphasic insulin aspart 30

Drug

Prescription at the discretion of the treating physician

Primary outcomes

  1. HbA1c (glycosylated haemoglobin)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Prandial Oriented NovoMix 30® - the Physiological Insulin Therapy of Diabetes Type 2

Acronym: ProMix

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Feb 22, 2012
Registry last updated
Mar 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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