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NCT01959529 · ClinicalTrials.gov registry record · Phase 3
A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events
A Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 7,637
- Enrollment target
- 20
- Study locations
NCT01959529: Completed Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.
NCT01959529 is a Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes that has completed, run by Novo Nordisk A/S. The registered enrollment target is 7,637 participants, above the 4,463-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (71% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01959529, a Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 7,637 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.
Primary Outcome
Time from randomisation to first occurrence of an event adjudication committee (EAC)-confirmed 3-component major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction, or nonfatal stroke. Events with EAC-confirmed onset date between randomisation and individual end of trial were included in the analyses. The number of subjects experiencing first EAC-confirmed MACEs, date between randomisation to the end of trial, both days included were presented. The trial w
Conditions Studied
Interventions
- DRUG insulin glargine
- DRUG insulin degludec
Study Locations (20)
Arizona
- Novo Nordisk Investigational Site - Gilbert
- Novo Nordisk Investigational Site - Glendale
- Novo Nordisk Investigational Site - Litchfield Park
- Novo Nordisk Investigational Site - Phoenix
- Novo Nordisk Investigational Site - Tucson
- Novo Nordisk Investigational Site - Tucson
- Novo Nordisk Investigational Site - Tucson
California
- Novo Nordisk Investigational Site - Chula Vista
- Novo Nordisk Investigational Site - Concord
- Novo Nordisk Investigational Site - Downey
- Novo Nordisk Investigational Site - Duarte
- Novo Nordisk Investigational Site - Encino
- Novo Nordisk Investigational Site - Fresno
Alabama
- Novo Nordisk Investigational Site - Birmingham
- Novo Nordisk Investigational Site - Birmingham
- Novo Nordisk Investigational Site - Montgomery
- Novo Nordisk Investigational Site - Montgomery
Arkansas
- Novo Nordisk Investigational Site - Little Rock
- Novo Nordisk Investigational Site - Little Rock
- Novo Nordisk Investigational Site - Searcy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7,637 participants |
| Start Date | 2013-10-29 |
| Est. Completion | 2016-10-16 |
| Phase | Phase 3 |
What the finished NCT01959529 record still lists
NCT01959529 is an interventional study that assigns participants to a tested intervention. Its 7,637 participants enrollment target places it among the larger protocols in the corpus, above the 4,463-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (71% higher).
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which insulin glargine is the first listed.
NCT01959529 names 20 study sites across 4 states, led by Arizona, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT01959529 about?
NCT01959529 is a clinical study titled "A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events". This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.
What is the current status of trial NCT01959529?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 7,637 participants. The study started on 2013-10-29. Estimated completion is 2016-10-16.
What conditions does trial NCT01959529 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes.
What interventions are being tested in trial NCT01959529?
The interventions under investigation include: insulin glargine (DRUG), insulin degludec (DRUG).
Who is sponsoring clinical trial NCT01959529?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01959529 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
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 NCT01959529's enrollment target sits among peer trials
7,637 14th of 348 higher than 335 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 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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