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Completed

NCT Number: NCT00771680

Observational Study to Evaluate the Effectiveness and Safety of Levemir®, NovoMix® 30 and NovoRapid® in Insulin naïve Subjects With Type 2 Diabetes

This study is conducted in Europe and Asia. The aim of this observational study is to evaluate the effectiveness and the incidence of serious adverse reactions while using Levemir®, NovoMix® and/or NovoRapid® in subjects with type 2 diabetes that have not used insulin previously 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

Novo Nordisk Investigational Site, Moscow, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any insulin näive type 2 diabetic patient that able to use the drug as judged by the investigator

Exclusion criteria

  • In accordance with approved label

Treatment and study plan

insulin detemir

Drug

Start dose and frequency at the discretion of the physician following clinical practice

biphasic insulin aspart 30

Drug

Start dose and frequency at the discretion of the physician following clinical practice

insulin aspart

Drug

Start dose and frequency at the discretion of the physician following clinical practice

Primary outcomes

  1. HbA1c

    Time frame: at baseline visit and during 3, 6, 9 and 12 months

  2. Serious adverse drug reactions including major hypoglycaemic events

    Time frame: during 12 months of treatment

Secondary outcomes

  1. Number of serious adverse drug reactions

    Time frame: during 12 months of treatment

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

    Time frame: during 12 months of treatment

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

    Time frame: During 4 weeks prior to each study visit

  4. Weight (BMI) change

    Time frame: At 6 and 12 months

  5. Variability in fasting blood glucose values and average (mean) fasting blood glucose level

    Time frame: At baseline visit and after 6 and 12 months treatment

  6. Average post-prandial blood glucose level (2h after dinner)

    Time frame: At baseline visit and after 6 and 12 months treatment

  7. Quality of Life (QoL) as assessed by patient questionnaire

    Time frame: At baseline and the end of 6 and 12 months treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Evaluation of Effectiveness and Safety of Levemir® (Insulin Detemir), NovoMix® (Biphasic Insulin Aspart) and/or NovoRapid® (Insulin Aspart) in Insulin naïve Subjects With Type 2 Diabetes.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 13, 2008
Registry last updated
Oct 28, 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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