A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)
A Study of LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring
2 other identifiers
interventional
187
2 countries
32
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes
Started Nov 2020
Shorter than P25 for phase_3 type-2-diabetes
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2020
CompletedFirst Posted
Study publicly available on registry
October 28, 2020
CompletedStudy Start
First participant enrolled
November 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2022
CompletedResults Posted
Study results publicly available
March 3, 2023
CompletedMarch 3, 2023
February 1, 2023
1.3 years
October 26, 2020
February 3, 2023
February 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Percentage of Time With Continuous Glucose Monitoring (CGM) Sensor Glucose Values Between 70-180 Milligrams/Deciliter (mg/dL) (3.9-10.0 Millimoles/Liter [mmol/L]) (Both Inclusive) During Daytime Period at Week 12
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Time as variables.
Baseline, Week 12
Secondary Outcomes (11)
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
Baseline, Week 12
Change From Baseline in Percentage of Time With CGM Sensor Glucose Values Between 70-180 mg/dL (3.9-10.0 mmol/L) (Both Inclusive) During the 24-hour Period at Week 12
Baseline, Week 12
Change From Baseline in Percentage of Time With CGM Sensor Glucose Values <54 mg/dL (<3.0 mmol/L) During Daytime and 24-hour Periods at Week 12
Baseline, Week 12
Change From Baseline in Percentage of Time With CGM Sensor Glucose Values >180 mg/dL (>10.0 mmol/L) During Daytime and 24-hour Period at Week 12
Baseline, Week 12
Change From Baseline in Percentage of Time With CGM Sensor Glucose Value >250 mg/dL (>13.9 mmol/L) During Daytime and 24-hour Period at Week 12
Baseline, Week 12
- +6 more secondary outcomes
Study Arms (1)
LY900014
EXPERIMENTALLY900014 (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.
Interventions
Eligibility Criteria
You may qualify if:
- Participants diagnosed (clinically) with type 2 diabetes mellitus (T2D) for at least 1 year prior to screening.
- 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:
- Metformin
- Dipeptidyl peptidase-4 (DPP-4) inhibitor
- sodium glucose cotransporter 2 (SGLT2) inhibitor
- 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.
You may not qualify if:
- Have been diagnosed at any time with type 1 diabetes mellitus or latent autoimmune diabetes in adults.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
John Muir Physician Network Clinical Research Center
Concord, California, 94520, United States
AMCR Institute
Escondido, California, 92025, United States
Valley Endocrine, Fresno
Fresno, California, 93720, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
Coastal Metabolic Research Centre
Ventura, California, 93003, United States
CMR of Greater New Haven
Hamden, Connecticut, 06517, United States
Encore Medical Research
Hollywood, Florida, 33021, United States
Sun Coast Clinical Research, Inc
New Port Richey, Florida, 34652, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
East Coast Institute for Research at The Jones Center
Macon, Georgia, 31210, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
Springfield, Illinois, 62711, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
Maryland Cardiovascular Specialists
Baltimore, Maryland, 21229, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, 20852, United States
Palm Research Center Tenaya
Las Vegas, Nevada, 89128, United States
Palm Research Center Tenaya
Las Vegas, Nevada, 89148, United States
Research NYC, Inc
New York, New York, 10016, United States
Suny Health Science Center at Syracuse
Syracuse, New York, 13210, United States
Cataret Medical Group
Morehead City, North Carolina, 28557, United States
Intend Research, LLC
Norman, Oklahoma, 73069, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78749, United States
Dallas Diabetes Research Center
Dallas, Texas, 75230, United States
Biopharma Informatic, LLC
Houston, Texas, 77043, United States
Endocrine Ips, Pllc
Houston, Texas, 77079, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Burke Internal Medicine and Research
Burke, Virginia, 22015, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Manati Center for Clinical Research Inc
Manatí, PR, 00674, Puerto Rico
Advanced Clinical Research, LLC
Bayamón, 00961, Puerto Rico
Related Publications (1)
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.
PMID: 37029268DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2020
First Posted
October 28, 2020
Study Start
November 4, 2020
Primary Completion
February 4, 2022
Study Completion
February 4, 2022
Last Updated
March 3, 2023
Results First Posted
March 3, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.