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Completed

NCT Number: NCT00873639

Observational Study of Type 1 Diabetics Switching From Human Insulins to Modern Insulin Analogues

This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoRapid® (insulin aspart) and Levemir® (insulin detemir) after switch from human insulins for treatment of type 1 diabetes under normal clinical practice conditions in Romania.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 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

Bucharest, 010031, Romania

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any subject with type 1 diabetes who is treated with human rapid and intermediate (NPH) insulin in basal-bolus regimen

Exclusion criteria

  • Subjects currently being treated with insulin aspart and insulin detemir
  • Subjects who were previously enrolled in this study
  • Subjects with a hypersensitivity to insulin aspart or to any of the excipients
  • Subjects with a hypersensitivity to insulin detemir or to any of the excipients
  • Women who are pregnant or have the intention of becoming pregnant within next 6 months

Treatment and study plan

insulin aspart

Drug

Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice

Other names: NovoRapid®, ANA

insulin detemir

Drug

Effectiveness and safety data collection in connection with the use of the drug NovoRapid® and Levemir® in routine clinical practice

Primary outcomes

  1. Change in HbA1c

    Time frame: at 24 weeks from baseline

Secondary outcomes

  1. Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5%

    Time frame: at 12 weeks and 24 weeks of treatment

  2. Change in FPG (glucose variability)

    Time frame: at 12 weeks and 24 weeks of treatment

  3. Change in PPG (postprandial control)

    Time frame: at 12 weeks and 24 weeks of treatment

  4. Change in insulin dose and number of injections

    Time frame: at 12 weeks and 24 weeks of treatment

  5. Change in body weight

    Time frame: at 12 weeks and 24 weeks of treatment

  6. Change in number of hypoglycaemic events

    Time frame: at 12 weeks and 24 weeks of treatment

  7. Number of adverse drug reactions (ADR)

    Time frame: at 12 weeks and 24 weeks of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoRapid® (Insulin Aspart) and Levemir® (Insulin Detemir) in a Basal-bolus Regimen for Treatment of Type 1 Diabetes Mellitus in Romania

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 1, 2009
Registry last updated
Oct 14, 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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