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Completed

NCT Number: NCT00709683

Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®

This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.

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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

Tunisia, 1053

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes having failed on basal insulin with or without OAD
  • HbA1c greater than 7.0%

Exclusion criteria

  • Subjects being unlikely to comply with protocol requirements
  • Subjects who previously enrolled in this study
  • Subjects with hypersensitivity to biphasic insulin aspart or any of the excipients
  • Women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method

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 major hypoglycaemic events reported as serious adverse drug reactions

    Time frame: during 26 weeks of treatment

Secondary outcomes

  1. Number of serious adverse drug reactions

    Time frame: during 26 weeks of treatment

  2. Number of serious adverse events

    Time frame: during 26 weeks of treatment

  3. Number of all major (daytime and nocturnal) hypoglycaemic events

    Time frame: during 26 weeks of treatment

  4. Number of all minor (daytime and nocturnal) hypoglycaemic events

    Time frame: during 26 weeks of treatment

  5. Weight (BMI) change from baseline

    Time frame: At the end of the study

  6. HbA1c change from baseline

    Time frame: At the end of the study

  7. Percentage of patients reaching the target of HbA1c of less than or equal to 7.0%

    Time frame: At the end of the study

  8. Average (mean) fasting plasma glucose level

    Time frame: At the end of the study

  9. Average post-breakfast (90-120 mins), post-lunch (90-120 mins), post-dinner (90-120 mins) plasma glucose level

    Time frame: At the end of the study

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Observational Study Evaluating the Safety and Efficacy of the Treatment With Biphasic Insulin Aspart (NovoMix® 30 FlexPen®) in the Treatment of Type 2 Diabetics After Failing on Basal/ Intermediate Mono or Combination Therapy

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 3, 2008
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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