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

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: Faster-acting insulin aspart; Drug: insulin aspart

• Registration Number: NCT01999322
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-19
• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-11-25
• Study First Posted: 2013-12-03
• Primary Completion: 2014-05-14
• Study Completion: 2014-05-14
• Disposition First Submitted: 2016-11-10
• Disposition First Submitted QC: 2016-11-10
• Disposition First Posted: 2016-11-11
• Status Verified: 2017-10
• Results First Submitted: 2017-10-02
• Results First Submitted QC: 2017-10-02
• Last Update Submitted: 2017-10-02
• Results First Posted: 2017-10-31
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FIAsp	Faster-acting insulin aspart	The trial duration is approximately 13 weeks and consists of a 1-week screening period, a 2-week run-in period, a 6-week treatment period and 1 week plus a 30-day follow-up period
Insulin Aspart	insulin aspart	The trial duration is approximately 13 weeks and consists of a 1-week screening period, a 2-week run-in period, a 6-week treatment period and 1 week plus a 30-day follow-up period

Primary Outcome Measures

Name	Time	Method
Number of Microscopically Confirmed Episodes of Infusion Set Occlusions	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 Outcome Measures

Name	Time	Method
Number of Unexplained Episodes of Hyperglycaemia (Confirmed by Self-measured Plasma Glucose (SMPG))	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)
Number of Episodes of Possible Infusion Set Occlusions	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.
Number of Premature Infusion Set Changes	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.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany