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OpenTrials
Completed

NCT Number: NCT01565733

Safety of Treatment Initiation With Biphasic Insulin Aspart 30 in Hospitalised Patients With Type 2 Diabetes

This study is conducted in Europe. The aim of this study is to evaluate the safety and efficacy of biphasic insulin aspart (NovoMix® 30) in hospitalised patients with type 2 diabetes with the aim of intensifying their treatment.

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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

Novo Nordisk Investigational Site

Warsaw, PL-02-274, Poland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with type 2 diabetes
  • Treated with oral anti-diabetics and/or human insulin

Exclusion criteria

  • Persons previously included in the trial
  • Hypersensitive to biphasic insulin aspart or any of the excipients
  • Pregnant or lactating women, or those who plan to get pregnant within the next 12 months

Treatment and study plan

biphasic insulin aspart 30

Drug

Biphasic insulin aspart 30 prescribed solely on the basis of clinical judgement. Initial dose, frequency of injections and further dosage amendments at the discretion of the treating physician.

Primary outcomes

  1. Frequency of severe hypoglycaemic episodes

Secondary outcomes

  1. Number of severe hypoglycaemic episodes

  2. Number of mild hypoglycaemic episodes

  3. Postprandial glucose concentration after breakfast, lunch, and dinner

  4. Average fasting glucose concentration after waking and before main meals

  5. Average plasma glucose level at bedtime and at night

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Multicenter, Open Label, Non-randomized, Non-interventional Observational Study of Safety of Treatment Initiation With a Biphasic Insulin Aspart (NovoMix® 30) in Hospitalized Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Mar 29, 2012
Registry last updated
Oct 31, 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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