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Completed

NCT Number: NCT01999322

A Trial Evaluating Compatibility and Safety of FIAsp and Insulin Aspart With an External Continuous Subcutaneous Insulin Infusion System in Adult Subjects With Type 1 Diabetes

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate compatibility and safety of FIAsp (faster-acting insulin aspart) and insulin aspart (NovoRapid®) with an external continuous subcutaneous insulin infusion (CSII) system in adult subjects with type 1 diabetes.

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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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Neuss, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, age at least 18 years at the time of signing inform consent
  • Type 1 diabetes mellitus (diagnosed clinically) for at least 12 months at the time of screening (Visit 1)
  • Currently treated with insulin aspart, insulin lispro or insulin gluisine for at least 3 months prior to screening (Visit 1)
  • Using an external CSII system for the previous 6 months prior to screening (Visit 1)
  • HbA1c (glycosylated haemoglobin) below or equal to 9.0% as assessed by central laboratory
  • Body Mass Index (BMI) 20.0-35.0 kg/m^2

Exclusion criteria

  • History of diabetic ketoacidosis (DKA) episodes requiring hospitalization within 6 months prior to screening (Visit 1)
  • History of abscess at the infusion site within 6 months prior to screening (Visit 1)
  • Hypoglycaemic unawareness as judged by the Investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to screening (Visit 1)

Treatment and study plan

Faster-acting insulin aspart

Drug

Administered subcutaneously (s.c., under the skin). Dose individually adjusted.

insulin aspart

Drug

Administered subcutaneously (s.c., under the skin). Dose individually adjusted.

Primary outcomes

  1. Number of Microscopically Confirmed Episodes of Infusion Set Occlusions

    Time frame: During 6 weeks of treatment

    The number of microscopically confirmed episodes of infusion set occlusions during 6 weeks of treatment. Episodes of infusion set occlusions were confirmed by microscopic examination of the infusion sets at each routine weekly visit and infusion sets that had been changed prematurely because of leakage, unexplained hyperglycaemia or suspicion of occlusion (observation of a plug).

Secondary outcomes

  1. Number of Unexplained Episodes of Hyperglycaemia (Confirmed by Self-measured Plasma Glucose (SMPG))

    Time frame: During 6 weeks of treatment

    Unexplained hyperglycaemia was defined as a confirmed plasma glucose value ≥ 16.7 mmol/L (300 mg/dL) and was unexplained (i.e., no apparent medical, dietary, insulin dosage or pump failure reason)

  2. Number of Episodes of Possible Infusion Set Occlusions

    Time frame: During 6 weeks of treatment

    Episodes of possible infusion set occlusions were defined as infusion sets changed due to suspicion of occlusion, leakage or unexplained hyperglycaemic episode. Possible occlusion excluded technical reasons. This endpoint was calculated from the recorded date/times of changes of infusion set combined with the subjects' own assessment.

  3. Number of Premature Infusion Set Changes

    Time frame: During 6 weeks of treatment

    A premature infusion set change was defined as not being a routine change. This was defined as an infusion set changed at home due to "suspicion of occlusion", "leakage", "unexplained hyperglycaemic episode", "infusion site reaction", "technical reason", or "other". The change of infusion set at a site visit was considered a routine change unless an occlusion was actually suspected at the site.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A 6-week Randomised, Double-blind, Parallel-group Trial Evaluating Compatibility and Safety of FIAsp and Insulin Aspart With an External Continuous Subcutaneous Insulin Infusion System in Adult Subjects With Type 1 Diabetes

Acronym: onset® 4

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 3, 2013
Registry last updated
Oct 31, 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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