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
NCT ID: NCT01999322
Last Updated: 2017-10-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
37 participants
INTERVENTIONAL
2013-11-19
2014-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Faster-acting insulin aspart
Administered subcutaneously (s.c., under the skin). Dose individually adjusted.
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
Administered subcutaneously (s.c., under the skin). Dose individually adjusted.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Atlanta, Georgia, United States
Novo Nordisk Investigational Site
Neuss, , Germany
Countries
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References
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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. 2018 Jan;12(1):145-151. doi: 10.1177/1932296817730375. Epub 2017 Sep 18.
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 http://press.endocrine.org/doi/abs/10.1210.endo-meetings.2016.DGM.22.FRI-697
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2013-002233-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1143-2316
Identifier Type: OTHER
Identifier Source: secondary_id
NN1218-3931
Identifier Type: -
Identifier Source: org_study_id