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

NCT01999322 | Completed Phase 3 Results

• 3 other identifiers: NN1218-39312013-002233-37U1111-1143-2316
• Study Type: interventional
• Target: 37
• Locations: 2 countries
• Sites: 2

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  During 6 weeks of treatment

• Number of Episodes of Possible Infusion Set Occlusions

  During 6 weeks of treatment

• Number of Premature Infusion Set Changes

  During 6 weeks of treatment

Study Arms (2)

FIAsp

EXPERIMENTAL

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

Drug: Faster-acting insulin aspart

Insulin Aspart

ACTIVE COMPARATOR

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

Drug: insulin aspart

Interventions

Faster-acting insulin aspart DRUG

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

FIAsp

insulin aspart DRUG

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

Insulin Aspart

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Novo Nordisk Investigational Site

Atlanta, Georgia, 30318, United States

Location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (2)

• 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.

  PMID: 28918652 BACKGROUND

• 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

  RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The trial was designed in accordance with the draft FDA guideline dated 1985, that 15-20 subjects with diabetes given the modified insulin should be included for 6 weeks. However the trial was not powered to detect differences between treatments.

Results Point of Contact

• Title: Global Clinical Registry (GCR, 1452)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 3, 2013
• Study Start: November 19, 2013
• Primary Completion: May 14, 2014
• Study Completion: May 14, 2014
• Last Updated: October 31, 2017
• Results First Posted: October 31, 2017

Record last verified: 2017-10

Locations

DE (1); US (1)