A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)

Completed · Phase 3

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT04605991

Run by

Eli Lilly and Company

People needed

187

Starts

2020-11-04

Expected to finish

2022-02-04

Last updated by the study team

2023-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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