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Completed

NCT Number: NCT00698269

An Observational Study of Efficacy and Safety of Modern Insulin in Diabetes Patients Switched From Anti-diabetic Treatment

This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries.

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Riyadh, 3542, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 or type 2 diabetes
  • Treatment with any diabetes treatment other than NovoMix® 30, Levemir® and/or NovoRapid®
  • Selection will be at the discretion of the individual physician

Exclusion criteria

  • Current treatment with Levemir®, NovoMix® 30 and/or NovoRapid®
  • Previous enrolled in this study
  • Hypersensitivity to Levemir®, NovoMix® 30 and/or NovoRapid® or to any of the excipients
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months

Treatment and study plan

insulin detemir

Drug

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

Other names: Levemir®

biphasic insulin aspart 30

Drug

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

insulin aspart

Drug

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

Primary outcomes

  1. Incidence of major hypoglycaemic events reported

    Time frame: during 24 weeks of treatment

  2. Change in HbA1c

    Time frame: during 24 weeks of treatment

Secondary outcomes

  1. Percentage of subjects achieving HbA1c below 7.0%

    Time frame: at 12 & 24 weeks

  2. Change in FPG

    Time frame: at 12 & 24 weeks

  3. Change in PPG

    Time frame: at 12 & 24 weeks

  4. Body weight

    Time frame: at 12 & 24 weeks

  5. Change in number of hypoglycaemic events in the last 4 weeks before routine visits

    Time frame: at 12 & 24 weeks

  6. Change in number of nocturnal Hypoglycaemic events in the last 4 weeks before routine visits

    Time frame: at 12 & 24 weeks

  7. Number of adverse drug reactions (ADR)

    Time frame: at 12 & 24 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety Study in Subjects Using Levemir® (Insulin Detemir), NovoMix®30 (Biphasic Insulin Aspart 30) and/or NovoRapid® (Insulin Aspart) for the Treatment of Type 1 or Type 2 Diabetes Mellitus

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 17, 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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