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NCT01618162 · ClinicalTrials.gov registry record · Phase 3
The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy
A Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 435
- Enrollment target
- 20
- Study locations
NCT01618162: Completed Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.
NCT01618162 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 435 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 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01618162, 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
- 435 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.
Primary Outcome
Change in HbA1c from baseline to 26 weeks.
Conditions Studied
Interventions
- DRUG placebo
- DRUG insulin degludec/liraglutide
Study Locations (20)
California
- Novo Nordisk Investigational Site - Anaheim
- Novo Nordisk Investigational Site - Garden Grove
- Novo Nordisk Investigational Site - La Jolla
- Novo Nordisk Investigational Site - Long Beach
- Novo Nordisk Investigational Site - Los Angeles
- Novo Nordisk Investigational Site - San Mateo
- Novo Nordisk Investigational Site - Walnut Creek
Florida
- Novo Nordisk Investigational Site - Kissimmee
- Novo Nordisk Investigational Site - Melbourne
- Novo Nordisk Investigational Site - Miami
- Novo Nordisk Investigational Site - Miami
Georgia
- Novo Nordisk Investigational Site - Atlanta
- Novo Nordisk Investigational Site - Roswell
Missouri
- Novo Nordisk Investigational Site - Chesterfield
- Novo Nordisk Investigational Site - Saint Charles
Idaho
- Novo Nordisk Investigational Site - Meridian
Illinois
- Novo Nordisk Investigational Site - Gurnee
Kentucky
- Novo Nordisk Investigational Site - Crestview Hills
Maryland
- Novo Nordisk Investigational Site - Rockville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 435 participants |
| Start Date | 2012-08-29 |
| Est. Completion | 2013-10-23 |
| Phase | Phase 3 |
What the finished NCT01618162 record still lists
NCT01618162 is an interventional study that assigns participants to a tested intervention. The registered 435 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 placebo is the first listed.
NCT01618162 names 20 study sites across 9 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01618162 about?
NCT01618162 is a clinical study titled "The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy". This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjec...
What is the current status of trial NCT01618162?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 435 participants. The study started on 2012-08-29. Estimated completion is 2013-10-23.
What conditions does trial NCT01618162 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes.
What interventions are being tested in trial NCT01618162?
The interventions under investigation include: placebo (DRUG), insulin degludec/liraglutide (DRUG).
Who is sponsoring clinical trial NCT01618162?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01618162 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Idaho, Illinois. 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 NCT01618162's enrollment target sits among peer trials
435 87th of 348 higher than 262 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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