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OpenTrials
Completed

NCT Number: NCT00675493

Observational Study of Type 1 and Type 2 Diabetes Patients Having Switched From Human Premixes to NovoMix®30

This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoMix® 30 for treatment of type 1 and type 2 diabetes under normal clinical practice conditions in Romania.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bucharest, 010031, Romania

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 and type 2 diabetics who are treated with human premix insulin (the selection of the subjects will be at the discretion of the individual physician).

Exclusion criteria

  • Subjects currently being treated with biphasic insulin aspart 30
  • Subjects who were previously enrolled in this study
  • Subjects with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
  • Women who are pregnant or have the intention of becoming pregnant within next 6 months
  • Children below 10 years of age

Treatment and study plan

biphasic insulin aspart 30

Drug

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

Other names: NovoMix® 30

Primary outcomes

  1. Change in HbA1c from baseline

    Time frame: For the duration of the study

Secondary outcomes

  1. Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5%

    Time frame: after 12 weeks and 24 weeks of treatment

  2. Change in FPG (glucose variability)

    Time frame: after 12 weeks and 24 weeks of treatment

  3. Change in PPG (postprandial control)

    Time frame: after 12 weeks and 24 weeks of treatment

  4. Change in insulin dose and number of injections

    Time frame: at 12 weeks and 24 weeks of treatment

  5. Change in oral antidiabetic drug therapy

    Time frame: after 12 weeks and 24 weeks of treatment

  6. Change in body weight

    Time frame: at 12 weeks and 24 weeks of treatment

  7. Change in number of hypoglycaemic events

    Time frame: during 4 weeks proceeding routine visits at 12 weeks and 24 weeks of treatment

  8. Number of adverse drug reactions (ADR)

    Time frame: after 12 weeks and 24 weeks of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Type 1 and Type 2 Diabetes Mellitus in Romania

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 9, 2008
Registry last updated
Feb 19, 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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