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NCT03078478 · ClinicalTrials.gov registry record · Phase 3
A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
A Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,609
- Enrollment target
- 20
- Study locations
NCT03078478: Completed Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.
NCT03078478 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 1,609 participants, below the 4,481-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03078478, 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
- 1,609 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is conducted in Europe and North America. The aim of the trial is to compare the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin with or without oral antidiabetic drugs. Due to change in glycaemic data collection process, this trial is amended to allow for a full 36 weeks (maintenance 2 period) of the use of the new process.
Primary Outcome
Severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks) period. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episod
Conditions Studied
Interventions
- DRUG Insulin glargine
- DRUG Insulin degludec
Study Locations (20)
California
- Novo Nordisk Investigational Site - Buena Park
- Novo Nordisk Investigational Site - Concord
- Novo Nordisk Investigational Site - Downey
- Novo Nordisk Investigational Site - Duarte
- Novo Nordisk Investigational Site - Fresno
- Novo Nordisk Investigational Site - La Jolla
- Novo Nordisk Investigational Site - Lancaster
- Novo Nordisk Investigational Site - Lomita
- Novo Nordisk Investigational Site - Los Alamitos
- Novo Nordisk Investigational Site - Los Angeles
- Novo Nordisk Investigational Site - Moreno Valley
Arizona
- Novo Nordisk Investigational Site - Chandler
- Novo Nordisk Investigational Site - Fountain Hills
- Novo Nordisk Investigational Site - Glendale
- Novo Nordisk Investigational Site - Glendale
- Novo Nordisk Investigational Site - Glendale
- Novo Nordisk Investigational Site - Phoenix
- Novo Nordisk Investigational Site - Tucson
Alabama
- Novo Nordisk Investigational Site - Anniston
- Novo Nordisk Investigational Site - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,609 participants |
| Start Date | 2017-03-13 |
| Est. Completion | 2019-03-04 |
| Phase | Phase 3 |
What the finished NCT03078478 record still lists
NCT03078478 is an interventional study that assigns participants to a tested intervention. Its 1,609 participants enrollment target places it among the larger protocols in the corpus, below the 4,481-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (64% 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.
NCT03078478 names 20 study sites across 3 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT03078478 about?
NCT03078478 is a clinical study titled "A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs". This trial is conducted in Europe and North America. The aim of the trial is to compare the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin with or without oral antidiabetic drugs. Due to chan...
What is the current status of trial NCT03078478?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,609 participants. The study started on 2017-03-13. Estimated completion is 2019-03-04.
What conditions does trial NCT03078478 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes.
What interventions are being tested in trial NCT03078478?
The interventions under investigation include: Insulin glargine (DRUG), Insulin degludec (DRUG).
Who is sponsoring clinical trial NCT03078478?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03078478 being conducted?
This trial has 20 study locations across Alabama, Arizona, 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 NCT03078478's enrollment target sits among peer trials
1,609 21st of 348 higher than 328 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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