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

Diabetes Clinical Trial

— onset® 4  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999322
• Other study ID #: NN1218-3931
• Secondary ID: 2013-002233-37U1
• Status: Completed
• Phase: Phase 3
• First received: November 25, 2013
• Last updated: October 2, 2017
• Start date: November 19, 2013
• Est. completion date: May 14, 2014

Study information

• Verified date: October 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 14, 2014
• Est. primary completion date: May 14, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Faster-acting insulin aspart
Administered subcutaneously (s.c., under the skin). Dose individually adjusted.
• insulin aspart
Administered subcutaneously (s.c., under the skin). Dose individually adjusted.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss
United States	Novo Nordisk Investigational Site	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (2)

Eric Zijlstra, Marek Demissie et al. Compatibility and Safety of Faster-Acting Insulin Aspart used in Continuous Subcutaneous Insulin Infusion Therapy in Patients with Type 1 Diabetes. ENDO-2016-98th Annual Meeting of the Endocrine Society 3 June 2016 htt

Zijlstra E, Demissie M, Graungaard T, Heise T, Nosek L, Bode B. Investigation of Pump Compatibility of Fast-Acting Insulin Aspart in Subjects With Type 1 Diabetes. J Diabetes Sci Technol. 2017 Sep 1:1932296817730375. doi: 10.1177/1932296817730375. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Microscopically Confirmed Episodes of Infusion Set Occlusions	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).	During 6 weeks of treatment
Secondary	Number of Unexplained Episodes of Hyperglycaemia (Confirmed by Self-measured Plasma Glucose (SMPG))	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)	During 6 weeks of treatment
Secondary	Number of Episodes of Possible Infusion Set Occlusions	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.	During 6 weeks of treatment
Secondary	Number of Premature Infusion Set Changes	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.	During 6 weeks of treatment

External Links

•   Clinical Trials at Novo Nordisk