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NCT01999322 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Diabetes and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 3
Development phase
37
Enrollment target
2
Study locations

NCT01999322: Completed Phase 3 study of Diabetes and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S.

NCT01999322 is a Phase 3 study of Diabetes and Diabetes Mellitus, Type 1 that has completed, run by Novo Nordisk A/S. The registered enrollment target is 37 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01999322, a Phase 3 study of Diabetes and Diabetes Mellitus, Type 1, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 3
Development phase
37 participants
Enrollment target
2
Study locations

Study 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.

Primary Outcome

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).

Interventions

  • DRUG insulin aspart
  • DRUG Faster-acting insulin aspart

Study Locations (2)

Georgia

  • Novo Nordisk Investigational Site - Atlanta

Other

  • Novo Nordisk Investigational Site - Neuss

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2013-11-19
Est. Completion 2014-05-14
Phase Phase 3
Novo Nordisk A/S

431 total trials

What the finished NCT01999322 record still lists

NCT01999322 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower).

The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 2 interventions - of which insulin aspart is the first listed.

NCT01999322 reports a single indexed study location in Georgia, Other.

Frequently Asked Questions

What is clinical trial NCT01999322 about?

NCT01999322 is a clinical study titled "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". 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 wi...

What is the current status of trial NCT01999322?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 37 participants. The study started on 2013-11-19. Estimated completion is 2014-05-14.

What conditions does trial NCT01999322 study?

This clinical trial studies the following conditions: Diabetes, Diabetes Mellitus, Type 1.

What interventions are being tested in trial NCT01999322?

The interventions under investigation include: insulin aspart (DRUG), Faster-acting insulin aspart (DRUG).

Who is sponsoring clinical trial NCT01999322?

This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01999322 being conducted?

This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Diabetes

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01999322's enrollment target sits among peer trials

37 271st of 338 higher than 67 of 338 other Diabetes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01999322, the US trial registry maintained by the National Library of Medicine. NCT01999322 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.