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NCT01835431 · ClinicalTrials.gov registry record · Phase 3

A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus

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

Completed
Registry status
Phase 3
Development phase
362
Enrollment target
20
Study locations

NCT01835431 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 362 participants, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT01835431, 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
362 participants
Enrollment target
20
Study locations

Study Summary

This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals in children and adolescents with type 1 diabetes mellitus.

Interventions

  • DRUG insulin aspart
  • DRUG insulin degludec/insulin aspart
  • DRUG insulin detemir

Study Locations (20)

Florida

  • Novo Nordisk Investigational Site - Jacksonville
  • Novo Nordisk Investigational Site - Maitland
  • Novo Nordisk Investigational Site - Melbourne
  • Novo Nordisk Investigational Site - Tallahassee
  • Novo Nordisk Investigational Site - Tampa

Arizona

  • Novo Nordisk Investigational Site - Phoenix
  • Novo Nordisk Investigational Site - Tucson

Georgia

  • Novo Nordisk Investigational Site - Atlanta
  • Novo Nordisk Investigational Site - Atlanta

California

  • Novo Nordisk Investigational Site - Sacramento

Colorado

  • Novo Nordisk Investigational Site - Aurora

Idaho

  • Novo Nordisk Investigational Site - Idaho Falls

Illinois

  • Novo Nordisk Investigational Site - Springfield

Indiana

  • Novo Nordisk Investigational Site - Indianapolis

Trial Details

FieldValue
Enrollment Target 362 participants
Start Date 2013-10-17
Est. Completion 2014-11-07
Phase Phase 3

Sponsor

Novo Nordisk A/S

431 total trials

What the Registry Record Tells You About NCT01835431

The ClinicalTrials.gov registry entry for NCT01835431 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 362 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (88% lower). The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 3 interventions - of which insulin aspart is the first listed.

NCT01835431 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Florida, Arizona, Georgia.

Frequently Asked Questions

What is clinical trial NCT01835431 about?

NCT01835431 is a clinical study titled "A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus". This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals in children and adolescents with type 1 diabetes mellitus.

What is the current status of trial NCT01835431?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 362 participants. The study started on 2013-10-17. Estimated completion is 2014-11-07.

What conditions does trial NCT01835431 study?

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

What interventions are being tested in trial NCT01835431?

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

Who is sponsoring clinical trial NCT01835431?

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

Where is trial NCT01835431 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.