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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 (onset® 4)

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ClinicalTrials.gov Identifier: NCT01999322
Recruitment Status : Completed
First Posted : December 3, 2013
Results First Posted : October 31, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE November 25, 2013
First Posted Date  ICMJE December 3, 2013
Results First Submitted Date  ICMJE October 2, 2017
Results First Posted Date  ICMJE October 31, 2017
Last Update Posted Date October 31, 2017
Actual Study Start Date  ICMJE November 19, 2013
Actual Primary Completion Date May 14, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
Number of Microscopically Confirmed Episodes of Infusion Set Occlusions [ Time Frame: During 6 weeks of treatment ]
Change History Complete list of historical versions of study NCT01999322 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2017)
  • 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)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
  • Number of Unexplained Episodes of Hyperglycaemia (Confirmed by Self-measured Plasma Glucose (SMPG)) [ Time Frame: During 6 weeks of treatment ]
  • Number of Episodes of Possible Infusion Set Occlusions [ Time Frame: During 6 weeks of treatment ]
  • Number of Premature Infusion Set Changes [ Time Frame: During 6 weeks of treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Drug: Faster-acting insulin aspart
    Administered subcutaneously (s.c., under the skin). Dose individually adjusted.
  • Drug: insulin aspart
    Administered subcutaneously (s.c., under the skin). Dose individually adjusted.
Study Arms  ICMJE
  • Experimental: FIAsp
    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
    Intervention: Drug: Faster-acting insulin aspart
  • Active Comparator: 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
    Intervention: Drug: insulin aspart
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2014)
37
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2013)
36
Actual Study Completion Date  ICMJE May 14, 2014
Actual Primary Completion Date May 14, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01999322
Other Study ID Numbers  ICMJE NN1218-3931
2013-002233-37 ( EudraCT Number )
U1111-1143-2316 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP