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Completed

NCT Number: NCT00729898

Observational Study to Observe the Safety of NovoMix® 30 Treatment in Patients With Type 2 Diabetes

This study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in patients with type 2 diabetes during NovoMix® 30 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, Rud, Norway

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any patient with diabetes type 2 diabetes
  • Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin
  • Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient

Exclusion criteria

  • Known or suspected allergy to study product(s) or related products
  • Pregnancy, breast-feeding or intention of becoming pregnant within the next 6 months

Treatment and study plan

biphasic insulin aspart 30

Drug

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Other names: NovoMix® 30

Primary outcomes

  1. Incidence of serious adverse drug reactions, including major hypoglycaemic events

    Time frame: after 12 and 26 weeks

Secondary outcomes

  1. Number of all hypoglycaemic events

    Time frame: in the 4 weeks preceding visit, at 12 weeks and the final visit at 26 weeks

  2. Number of all adverse drug reactions

    Time frame: after 12 and 26 weeks

  3. HbA1c

    Time frame: at 12 and 26 weeks

  4. Variability in fasting plasma glucose (FPG) values and average FPG levels

    Time frame: at visits at 12 and 26 weeks

  5. Weight changes

    Time frame: at visits at 12 and 26 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Safety of NovoMix® 30 (Biphasic Insulin Aspart) Treatment in Patients With Type 2 Diabetes

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 8, 2008
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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