A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)
NCT ID: NCT04605991
Last Updated: 2023-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
187 participants
INTERVENTIONAL
2020-11-04
2022-02-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LY900014
LY900014 (100 units/milliliter (U/mL)) is a mealtime insulin administered subcutaneously (SC) 0-2 minutes prior to each meal in combination with insulin glargine (100 U/mL) SC as long-acting insulin. Mealtime (bolus) and long-acting (basal) insulin doses were titrated to achieve glucose targets during the study.
LY900014
Administered SC
Insulin Glargine
Administered SC
Interventions
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LY900014
Administered SC
Insulin Glargine
Administered SC
Eligibility Criteria
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Inclusion Criteria
* Have been treated with basal-bolus multiple daily injection (MDI) therapy for at least 90 days prior to screening including:
* Basal insulin glargine U-100, in combination with bolus insulin analog (insulin lispro, insulin aspart, or insulin glulisine) with meals.
* Participant must have been treated with the same type of allowed bolus insulin analog for at least 30 days prior to screening.
* Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) for T2D in accordance with local regulations:
1. Metformin
2. Dipeptidyl peptidase-4 (DPP-4) inhibitor
3. sodium glucose cotransporter 2 (SGLT2) inhibitor
4. oral glucagon-like peptide 1 (GLP-1) agonist
* Doses of OAMs are required to have been stable for at least 90 days prior to screening.
* Participants may be treated with injectable GLP-1 receptor agonist for T2D in accordance with local regulations. The GLP-1 receptor agonist dose is required to have been stable for at least 90 days prior to screening.
* Have an HbA1c value ≥7.5% and ≤10% according to the central laboratory at screening.
Exclusion Criteria
* Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to screening.
* Have had any episode of hyperglycemic hyperosmolar state or diabetic ketoacidosis within 6 months prior to screening.
* Have hypoglycemia unawareness as judged by the investigator.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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John Muir Physician Network Clinical Research Center
Concord, California, United States
AMCR Institute
Escondido, California, United States
Valley Endocrine, Fresno
Fresno, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
Coastal Metabolic Research Centre
Ventura, California, United States
CMR of Greater New Haven
Hamden, Connecticut, United States
Encore Medical Research
Hollywood, Florida, United States
Sun Coast Clinical Research, Inc
New Port Richey, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
East Coast Institute for Research at The Jones Center
Macon, Georgia, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
Springfield, Illinois, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Maryland Cardiovascular Specialists
Baltimore, Maryland, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, United States
Palm Research Center Tenaya
Las Vegas, Nevada, United States
Palm Research Center Tenaya
Las Vegas, Nevada, United States
Research NYC, Inc
New York, New York, United States
Suny Health Science Center at Syracuse
Syracuse, New York, United States
Cataret Medical Group
Morehead City, North Carolina, United States
Intend Research, LLC
Norman, Oklahoma, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Endocrine Ips, Pllc
Houston, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Burke Internal Medicine and Research
Burke, Virginia, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Rainier Clinical Research Center
Renton, Washington, United States
Manati Center for Clinical Research Inc
Manatí, PR, Puerto Rico
Advanced Clinical Research, LLC
Bayamón, , Puerto Rico
Countries
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References
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Bailey TS, Bode BW, Wang Q, Knights AW, Chang AM. Increased Time in Range with Ultra Rapid Lispro Treatment in Participants with Type 2 Diabetes: PRONTO-Time in Range. Diabetes Ther. 2023 May;14(5):883-897. doi: 10.1007/s13300-023-01400-w. Epub 2023 Apr 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Mealtime Insulin LY900014 in Participants with Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)
Other Identifiers
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I8B-MC-ITSW
Identifier Type: OTHER
Identifier Source: secondary_id
17428
Identifier Type: -
Identifier Source: org_study_id
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