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OpenTrials
Completed

NCT Number: NCT00869908

Observational Study on the Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or Combined) in Type 2 Diabetics Previously Treated With Anti-diabetic Medication

This study is conducted in Africa, Asia, South America and Europe. The aim of this observational study is to document the experience with the study insulins when used in routine clinical practice. After the physician's decision to start insulin treatment using NovoMix® 30, Levemir® or NovoRapid® (alone or combined), type 2 diabetics will be eligible to be included in this study at the physician's discretion

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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, Algiers, Algeria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • After the physician has taken the decision to use NovoMix®30, Levemir® or NovoRapid® (alone or combined), any subject with type 2 diabetes who is not treated with these insulins or who has started on these insulin within the last 4 weeks before inclusion into this study is eligible for the study.
  • The selection of the subjects will be at the discretion of the individual physician.

Exclusion criteria

  • Subjects treated with NovoMix® 30, Levemir® or NovoRapid® (alone or in combination) for more than 4 weeks before inclusion into this study.
  • Subjects who were previously enrolled in this study.
  • Subjects with a hypersensitivity to NovoMix® 30, Levemir® or NovoRapid® or to any of the excipients.
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months.

Treatment and study plan

insulin aspart

Drug

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

Other names: NovoRapid®, ANA

insulin detemir

Drug

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

biphasic insulin aspart

Drug

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

Primary outcomes

  1. Number of serious adverse drug reactions and major hypoglycaemic events reported as serious adverse drug reactions

    Time frame: at baseline, 12 weeks and 24 weeks

Secondary outcomes

  1. Evaluate the prescribing patterns and choice of insulin analogues in routine clinical practice

    Time frame: at baseline, 12 weeks and 24 weeks

  2. Change in number of hypoglycaemic events

    Time frame: at baseline, 12 weeks and 24 weeks

  3. Change in HbA1c

    Time frame: at baseline, 12 weeks and 24 weeks

  4. Change in FPG (Fasting Plasma Glucose)

    Time frame: at baseline, 12 weeks and 24 weeks

  5. Change in PPG (postprandial glucose)

    Time frame: at baseline, 12 weeks and 24 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

The Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or in Combination) in Subjects With Type 2 Diabetes Previously Treated With Other Anti-diabetic Medication. A 24-week, International, Prospective, Multi-centre, Open-labelled, Non-interventional Study

Acronym: A1chieve®

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 26, 2009
Registry last updated
Jan 19, 2017

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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