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Completed

NCT Number: NCT00755833

Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months

This study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective is also to observe the different regimes of starting and maintaining the treatment with NovoMix® 50 during one year.

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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

Ljubljana, SI-1000, Slovenia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes treated with biphasic human insulin with or without metformin
  • Inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the physician's opinion, benefit from treatment with NovoMix® 50

Exclusion criteria

  • Subjects with diagnosed type 1 diabetes mellitus
  • Subjects treated with short acting or intermediate acting human insulin or any insulin analogue
  • Subjects who are unlikely to comply with study description, e.g. uncooperative attitude, inability to come for regular visits
  • Subjects with a hypersensitivity to biphasic insulin aspart 50 (NovoMix® 50 )or to any of the excipients
  • Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months

Treatment and study plan

biphasic insulin aspart 50

Drug

Efficacy and safety data collection in connection with the use of the drug NovoMix® 50 in daily clinical practice.

Other names: NovoMix® 50

Primary outcomes

  1. Change in HbA1c

    Time frame: At 0, 3, 6, 9, 12 months

Secondary outcomes

  1. Percentage of subjects achieving target HbA1c

    Time frame: At 0, 3, 6, 9, 12 months

  2. Change in FPG (fasting plasma glucose)

    Time frame: At 0, 3, 6, 9, 12 months

  3. Change in PPG (postprandial glucose)

    Time frame: At 0, 3, 6, 9, 12 months

  4. Change in number of hypoglycaemic events

    Time frame: At 0, 3, 6, 9, 12 months

  5. Change in insulin presentation

    Time frame: At 0, 3, 6, 9, 12 months

  6. Dose and number of injections

    Time frame: At 0, 3, 6, 9, 12 months

  7. Number of ADRs (adverse drug reaction)

    Time frame: At 0, 3, 6, 9, 12 months

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Prospective, Multicentre, Open Label, Un-controlled , Observational, 12-month Study in Subjects Using: NovoMix® 50 (Biphasic Insulin Aspart 50) for Treatment of Type 2 Diabetes Mellitus in Slovenia

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 19, 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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