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Completed

NCT Number: NCT00699179

Observational Study to Evaluate the Efficacy and Safety of NovoMix® 30 in Type 1 and 2 Diabetes

This study is conducted in Europe. This observational study is aimed to reflect the post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used under normal clinical practice conditions in Serbia.

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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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Belgrade, 11 070, Serbia and Montenegro

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 Mellitus inadequately controlled on human insulin therapy lasting for at least 6 months
  • HbA1c greater than 7%
  • Informed Consent

Exclusion criteria

  • Patients with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
  • Other limiting conditions specified in the locally approved NovoMix 30 SPC ( Summary of Product Characteristics), PIL ( Patient Information Leaflet).
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next couple of months

Treatment and study plan

biphasic insulin aspart 30

Drug

There is no intervention in this trial. The trial is prepared to be non-interventional one. Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation.

Other names: NovoMix® 30

Primary outcomes

  1. Change in HbA1c from baseline

    Time frame: After 6 months

Secondary outcomes

  1. Percentage of patients achieving HbA1c below 7,5% for Type 1 Diabetes Mellitus, below 7.0% and below or equal to 6.5% for Type 2 Diabetes Mellitus

    Time frame: after 12 weeks and 26 weeks compared to baseline

  2. Change in FPG (glucose variability)

    Time frame: after 12 weeks and 26 weeks compared to baseline

  3. Change in PPG (postprandial control)

    Time frame: after 12 weeks and 26 weeks compared to baseline

  4. Change in insulin dose and number of injections

    Time frame: at 12 weeks and 26 weeks of treatment

  5. Change in oral antidiabetic drug therapy dosage and eventual discontinuation of oral antidiabetic drug therapy during the study

    Time frame: after 12 weeks and 26 weeks of treatment compared to baseline

  6. Change in body weight and waist circumference

    Time frame: at 12 weeks and 26 weeks of treatment compared to baseline

  7. Change in number of major hypoglycaemic events during 4 weeks proceeding routine visits

    Time frame: at 12 weeks and 26 weeks of treatment compared to baseline

  8. Number of adverse drug reactions (ADR)

    Time frame: after 12 weeks and 26 weeks of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

EFFicacious glycaEmia Control, Treatment Goal achIevement Very simplE With NovoMix 30: A Single-country, Multicentre, Prospective, Open Label, Non-controlled, Observational, 26-week Study in Serbian Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Diabetes Mellitus in Everyday Clinical Practice

Acronym: EFFECTIVE

Important dates

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