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NCT02302716 · ClinicalTrials.gov registry record · Phase 3
A Study of LY2963016 Compared to LANTUS® in Adult Participants With Type 2 Diabetes Mellitus
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 493
- Enrollment target
- 20
- Study locations
NCT02302716: Completed Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Eli Lilly and Company.
NCT02302716 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Eli Lilly and Company. The registered enrollment target is 493 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02302716, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 493 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as LY2963016 as compared to LANTUS® in adults with type 2 diabetes mellitus who are on 2 or more oral antihyperglycemic medications (OAMs).
Primary Outcome
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, treatment (LY2963016, LANTUS), pooled country, basal insulin at entry (yes/no), sulfonylurea (SU) use (yes/no), visit, treatment and visit\*treatment in the model.
Conditions Studied
Interventions
- DRUG LY2963016
- DRUG LANTUS®
- DRUG Oral Antihyperglycemic Medication
Study Locations (20)
Other
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Ahmedabad
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Chennai
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Hyderabad
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Jaipur
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Kormangala
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Mumbai
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - New Delhi
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Panjim
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Pune
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Secunderabad
Florida
- New Horizon Research Center - Miami
- Suncoast Clinical Research - New Port Richey
Georgia
- Atlanta Vanguard Medical Associates - Smyrna
Kansas
- Cotton O'Neil Clinic - Topeka
New York
- Manhattan Medical Research - New York
Ohio
- Aventiv Research - Columbus
Tennessee
- University Diabetes and Endocrine Consultants - Chattanooga
Texas
- Dallas Diabetes Endocrine Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 493 participants |
| Start Date | 2014-12 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
What the finished NCT02302716 record still lists
NCT02302716 is an interventional study that assigns participants to a tested intervention. The registered 493 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 (89% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 3 interventions - of which LY2963016 is the first listed.
NCT02302716 names 20 study sites across 10 states, led by Other, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT02302716 about?
NCT02302716 is a clinical study titled "A Study of LY2963016 Compared to LANTUS® in Adult Participants With Type 2 Diabetes Mellitus". The main purpose of this study is to evaluate the safety and efficacy of the study drug known as LY2963016 as compared to LANTUS® in adults with type 2 diabetes mellitus who are on 2 or more oral antihyperglycemic medications (OAMs).
What is the current status of trial NCT02302716?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 493 participants. The study started on 2014-12. Estimated completion is 2016-07.
What conditions does trial NCT02302716 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT02302716?
The interventions under investigation include: LY2963016 (DRUG), LANTUS® (DRUG), Oral Antihyperglycemic Medication (DRUG).
Who is sponsoring clinical trial NCT02302716?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02302716 being conducted?
This trial has 20 study locations across Florida, Georgia, Kansas, New York, Ohio. 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 NCT02302716's enrollment target sits among peer trials
493 80th of 348 higher than 269 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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