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NCT01819129 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
A Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 881
- Enrollment target
- 20
- Study locations
NCT01819129: Completed Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.
NCT01819129 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 881 participants, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01819129, 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
- 881 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin glargine and metformin in adults with type 2 diabetes.
Primary Outcome
The primary endpoint was change from baseline in HbA1c after 26 weeks of randomized treatment. For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.
Conditions Studied
Interventions
- DRUG Insulin aspart
- DRUG Insulin glargine
- DRUG Faster-acting insulin aspart
Study Locations (20)
California
- Novo Nordisk Investigational Site - Anaheim
- Novo Nordisk Investigational Site - Fresno
- Novo Nordisk Investigational Site - Greenbrae
- Novo Nordisk Investigational Site - Lomita
- Novo Nordisk Investigational Site - Northridge
- Novo Nordisk Investigational Site - San Diego
- Novo Nordisk Investigational Site - San Ramon
- Novo Nordisk Investigational Site - Walnut Creek
Arizona
- Novo Nordisk Investigational Site - Glendale
- Novo Nordisk Investigational Site - Glendale
- Novo Nordisk Investigational Site - Mesa
- Novo Nordisk Investigational Site - Phoenix
- Novo Nordisk Investigational Site - Tempe
Florida
- Novo Nordisk Investigational Site - Boynton Beach
- Novo Nordisk Investigational Site - Bradenton
- Novo Nordisk Investigational Site - Cooper City
- Novo Nordisk Investigational Site - Fort Lauderdale
Colorado
- Novo Nordisk Investigational Site - Aurora
- Novo Nordisk Investigational Site - Colorado Springs
Connecticut
- Novo Nordisk Investigational Site - Waterbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 881 participants |
| Start Date | 2013-09-09 |
| Est. Completion | 2015-01-22 |
| Phase | Phase 3 |
What the finished NCT01819129 record still lists
NCT01819129 is an interventional study that assigns participants to a tested intervention. The registered 881 participants enrollment target is mid-sized for trials with a published cap, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 3 interventions - of which Insulin aspart is the first listed.
NCT01819129 names 20 study sites across 5 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT01819129 about?
NCT01819129 is a clinical study titled "Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes". This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin glargine and metformin in adults with type 2 diabetes.
What is the current status of trial NCT01819129?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 881 participants. The study started on 2013-09-09. Estimated completion is 2015-01-22.
What conditions does trial NCT01819129 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes.
What interventions are being tested in trial NCT01819129?
The interventions under investigation include: Insulin aspart (DRUG), Insulin glargine (DRUG), Faster-acting insulin aspart (DRUG).
Who is sponsoring clinical trial NCT01819129?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01819129 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. 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 NCT01819129's enrollment target sits among peer trials
881 41st of 348 higher than 308 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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