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NCT01421147 · ClinicalTrials.gov registry record · Phase 3
A Study in Adults With Type 1 Diabetes
A Phase 3 study of Diabetes Mellitus, Type 1, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 536
- Enrollment target
- 20
- Study locations
NCT01421147: Completed Phase 3 study of Diabetes Mellitus, Type 1, sponsored by Eli Lilly and Company.
NCT01421147 is a Phase 3 study of Diabetes Mellitus, Type 1 that has completed, run by Eli Lilly and Company. The registered enrollment target is 536 participants, below the 1,262-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01421147, a Phase 3 study of Diabetes Mellitus, Type 1, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 536 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.
Primary Outcome
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Conditions Studied
Interventions
- DRUG Insulin Lispro
- DRUG LY2963016
- DRUG Lantus
Study Locations (20)
Florida
- 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. - Hollywood
- 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 Port Richey
- 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. - West Palm Beach
New York
- 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. - Mineola
- 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 Hyde Park
- 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. - Syracuse
Georgia
- 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. - Atlanta
- 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. - Roswell
Texas
- 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. - Austin
- 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. - Dallas
Alabama
- 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. - Birmingham
Illinois
- 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. - Springfield
Iowa
- 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. - Des Moines
Kansas
- 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. - Topeka
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 536 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
What the finished NCT01421147 record still lists
NCT01421147 is an interventional study that assigns participants to a tested intervention. The registered 536 participants enrollment target is mid-sized for trials with a published cap, below the 1,262-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 3 interventions - of which Insulin Lispro is the first listed.
NCT01421147 names 20 study sites across 14 states, led by Florida, New York, Georgia.
Frequently Asked Questions
What is clinical trial NCT01421147 about?
NCT01421147 is a clinical study titled "A Study in Adults With Type 1 Diabetes". The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.
What is the current status of trial NCT01421147?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 536 participants. The study started on 2011-08. Estimated completion is 2013-04.
What conditions does trial NCT01421147 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT01421147?
The interventions under investigation include: Insulin Lispro (DRUG), LY2963016 (DRUG), Lantus (DRUG).
Who is sponsoring clinical trial NCT01421147?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01421147 being conducted?
This trial has 20 study locations across Alabama, Florida, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
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 NCT01421147's enrollment target sits among peer trials
536 13th of 118 higher than 106 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 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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