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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: Completed Phase 3 study of Diabetes and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage point change in glycosylated haemoglobin A1c (HbA1c) from baseline (week 0) to 16 Weeks. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 362 participants |
| Start Date | 2013-10-17 |
| Est. Completion | 2014-11-07 |
| Phase | Phase 3 |
What the finished NCT01835431 record still lists
NCT01835431 is an interventional study that assigns participants to a tested intervention. The registered 362 participants enrollment target is mid-sized for trials with a published cap, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (88% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
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 NCT01835431's enrollment target sits among peer trials
362 96th of 338 higher than 242 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.
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