A Study of LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring

Who is this study for? Adult patients with type 2 diabetes
What treatments are being studied? LY900014+Insulin Glargine
Status: Completed
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
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
Connecticut
CMR of Greater New Haven
Hamden
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
Iowa
Iowa Diabetes and Endocrinology Research Center
West Des Moines
Idaho
Rocky Mountain Clinical Research
Idaho Falls
Illinois
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
Springfield
Maryland
Maryland Cardiovascular Specialists
Baltimore
Endocrine and Metabolic Consultants
Rockville
North Carolina
Cataret Medical Group
Morehead City
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
Oklahoma
Intend Research, LLC
Norman
Texas
Texas Diabetes & Endocrinology, P.A.
Austin
Dallas Diabetes Research Center
Dallas
Biopharma Informatic, LLC
Houston
Endocrine Ips, Pllc
Houston
Consano Clinical Research, LLC
Shavano Park
Virginia
Burke Internal Medicine and Research
Burke
Manassas Clinical Research Center
Manassas
Washington
Rainier Clinical Research Center
Renton
Other Locations
Puerto Rico
Advanced Clinical Research, LLC
Bayamon
Manati Center for Clinical Research Inc
Manati
Time Frame
Start Date: 2020-11-04
Completion Date: 2022-02-04
Participants
Target number of participants: 187
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov