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NCT01045447 · ClinicalTrials.gov registry record · Phase 3
Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects 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
- 465
- Enrollment target
- 20
- Study locations
NCT01045447: Completed Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.
NCT01045447 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 465 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01045447, 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
- 465 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the trial.
Primary Outcome
Change from baseline in HbA1c after 26 weeks of treatment.
Conditions Studied
Interventions
- DRUG insulin glargine
- DRUG insulin degludec/insulin aspart
Study Locations (20)
Florida
- Novo Nordisk Investigational Site - Boynton Beach
- Novo Nordisk Investigational Site - Clearwater
- Novo Nordisk Investigational Site - Jacksonville
- Novo Nordisk Investigational Site - Kissimmee
- Novo Nordisk Investigational Site - New Port Richey
- Novo Nordisk Investigational Site - Orlando
- Novo Nordisk Investigational Site - Pembroke Pines
- Novo Nordisk Investigational Site - Tampa
Maryland
- Novo Nordisk Investigational Site - Baltimore
- Novo Nordisk Investigational Site - Hyattsville
Michigan
- Novo Nordisk Investigational Site - Southfield
- Novo Nordisk Investigational Site - Southfield
California
- Novo Nordisk Investigational Site - Fresno
Connecticut
- Novo Nordisk Investigational Site - Waterbury
Georgia
- Novo Nordisk Investigational Site - Atlanta
Iowa
- Novo Nordisk Investigational Site - Des Moines
Massachusetts
- Novo Nordisk Investigational Site - Waltham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 465 participants |
| Start Date | 2010-01 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
What the finished NCT01045447 record still lists
NCT01045447 is an interventional study that assigns participants to a tested intervention. The registered 465 participants enrollment target is mid-sized for trials with a published cap, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (90% lower).
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.
NCT01045447 names 20 study sites across 11 states, led by Florida, Maryland, Michigan.
Frequently Asked Questions
What is clinical trial NCT01045447 about?
NCT01045447 is a clinical study titled "Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes". This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OAD...
What is the current status of trial NCT01045447?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 465 participants. The study started on 2010-01. Estimated completion is 2010-10.
What conditions does trial NCT01045447 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes.
What interventions are being tested in trial NCT01045447?
The interventions under investigation include: insulin glargine (DRUG), insulin degludec/insulin aspart (DRUG).
Who is sponsoring clinical trial NCT01045447?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01045447 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Iowa. 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 NCT01045447's enrollment target sits among peer trials
465 85th of 348 higher than 264 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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