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NCT04605991 · ClinicalTrials.gov registry record · Phase 3
A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)
A Phase 3 study of Type 2 Diabetes, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 187
- Enrollment target
- 20
- Study locations
NCT04605991: Completed Phase 3 study of Type 2 Diabetes, sponsored by Eli Lilly and Company.
NCT04605991 is a Phase 3 study of Type 2 Diabetes that has completed, run by Eli Lilly and Company. The registered enrollment target is 187 participants, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04605991, a Phase 3 study of Type 2 Diabetes, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 187 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is being done to evaluate glycemic control in participants with type 2 diabetes who are taking mealtime insulin LY900014 in combination with long-acting insulin glargine. Participants will use continuous glucose monitoring (CGM) (Freestyle Libre 14-day system) during the study.
Primary Outcome
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Time as variables.
Conditions Studied
Interventions
- DRUG Insulin Glargine
- DRUG LY900014
Study Locations (20)
California
- John Muir Physician Network Clinical Research Center - Concord
- AMCR Institute - Escondido
- Valley Endocrine, Fresno - Fresno
- University Clinical Investigators, Inc. - Tustin
- Coastal Metabolic Research Centre - Ventura
Florida
- Encore Medical Research - Hollywood
- Sun Coast Clinical Research, Inc - New Port Richey
- Metabolic Research Institute, Inc. - West Palm Beach
Georgia
- Atlanta Diabetes Associates - Atlanta
- East Coast Institute for Research at The Jones Center - Macon
Maryland
- Maryland Cardiovascular Specialists - Baltimore
- Endocrine and Metabolic Consultants - Rockville
Nevada
- Palm Research Center Tenaya - Las Vegas
- Palm Research Center Tenaya - Las Vegas
New York
- Research NYC, Inc - New York
- Suny Health Science Center at Syracuse - Syracuse
Connecticut
- CMR of Greater New Haven - Hamden
Idaho
- Rocky Mountain Clinical Research - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2020-11-04 |
| Est. Completion | 2022-02-04 |
| Phase | Phase 3 |
What the finished NCT04605991 record still lists
NCT04605991 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Insulin Glargine is the first listed.
NCT04605991 names 20 study sites across 10 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04605991 about?
NCT04605991 is a clinical study titled "A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)". This study is being done to evaluate glycemic control in participants with type 2 diabetes who are taking mealtime insulin LY900014 in combination with long-acting insulin glargine. Participants will use continuous glucose monitoring (CGM) (Freestyle Libre 14-day system) during the study.
What is the current status of trial NCT04605991?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 187 participants. The study started on 2020-11-04. Estimated completion is 2022-02-04.
What conditions does trial NCT04605991 study?
This clinical trial studies the following conditions: Type 2 Diabetes.
What interventions are being tested in trial NCT04605991?
The interventions under investigation include: Insulin Glargine (DRUG), LY900014 (DRUG).
Who is sponsoring clinical trial NCT04605991?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04605991 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes
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 NCT04605991's enrollment target sits among peer trials
187 106th of 327 higher than 222 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes 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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