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NCT02034513 · ClinicalTrials.gov registry record · Phase 3

A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes

A Phase 3 study, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 3
Development phase
501
Enrollment target

NCT02034513: Completed Phase 3 study, sponsored by Novo Nordisk A/S.

NCT02034513 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 501 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02034513, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 3
Development phase
501 participants
Enrollment target

Study Summary

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar), both with insulin aspart (IAsp) as mealtime insulin in subjects with type 1 diabetes.

Primary Outcome

Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of \<3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Maintenance period: 16 weeks of treatment, in each treatment perio

Interventions

  • DRUG insulin aspart
  • DRUG insulin glargine
  • DRUG insulin degludec

Trial Details

FieldValue
Enrollment Target 501 participants
Start Date 2014-01-05
Est. Completion 2016-01-11
Phase Phase 3
Novo Nordisk A/S

431 total trials

What the finished NCT02034513 record still lists

NCT02034513 is an interventional study that assigns participants to a tested intervention. The registered 501 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).

The record links to 0 conditions, and to 3 interventions - of which insulin aspart is the first listed.

NCT02034513 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02034513 about?

NCT02034513 is a clinical study titled "A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes". This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar), both with insulin aspart (IAsp) as mealtime insulin in subjects with type 1 diabetes.

What is the current status of trial NCT02034513?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 501 participants. The study started on 2014-01-05. Estimated completion is 2016-01-11.

What interventions are being tested in trial NCT02034513?

The interventions under investigation include: insulin aspart (DRUG), insulin glargine (DRUG), insulin degludec (DRUG).

Who is sponsoring clinical trial NCT02034513?

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

How this trial's enrollment target compares

Where NCT02034513's enrollment target sits among peer trials

501 743rd of 2000 higher than 1,257 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT02034513, the US trial registry maintained by the National Library of Medicine. NCT02034513 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.