A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes

Completed · Phase 3

Conditions studied: Type 2 Diabetes Mellitus

In brief

The purpose of this study is to compare LY900014 to insulin lispro, both in combination with insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).

Key facts

Study ID

NCT03214380

Run by

Eli Lilly and Company

People needed

933

Starts

2017-07-14

Expected to finish

2019-03-13

Last updated by the study team

2020-03-27

Who can join

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

You may qualify if…

• Have been diagnosed (clinically) with T2D, based on the World Health Organization (WHO) classification for at least 1 year prior to screening.
• Have been treated for at least 90 days prior to screening with:
• Basal insulin (insulin glargine U-100 [Basaglar/Abasaglar or LANTUS] or U-300, insulin detemir, insulin degludec U-100 or U-200, or neutral protamine Hagedorn [NPH] insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro U-100 or U-200, insulin aspart, insulin glulisine, or regular insulin) Or
• Premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily
• Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) in accordance with local regulations:
• Metformin
• Dipeptidyl peptidase-4 (DPP-4) inhibitor
• Sodium glucose cotransporter 2 (SGLT2) inhibitor
• Sulfonylurea
• Meglitinide
• Alpha-glucoside inhibitor
• Have an HbA1c value between ≥7.0 and ≤10.0%, according to the central laboratory at the time of screening.
• Have a body mass index (BMI) of ≤45.0 kilograms per meter squared at screening.

You may not qualify if…

• Have been diagnosed, at any time, with type 1 diabetes (T1D) or Latent Autoimmune Diabetes in Adults.
• Have hypoglycemia unawareness as judged by the investigator.
• Have had any episode of severe hypoglycemia within the 6 months prior to screening.
• Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
• Have used thiazolidinediones, Glucagon-Like Peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.

Where it is running

• Diabetes and Endocrine Associates — La Mesa, California, United States
• First Valley Medical Group — Lancaster, California, United States
• National Research Institute — Los Angeles, California, United States
• Care Access Research — Santa Clarita, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• ALL Medical Research, LLC — Cooper City, Florida, United States
• The Center For Diabetes & Endocrine Care — Fort Lauderdale, Florida, United States
• East Coast Institute For Research — Jacksonville, Florida, United States
• Sun Coast Clinical Research, Inc — New Port Richey, Florida, United States
• East West Medical Institute — Honolulu, Hawaii, United States
• Elite Clinical Trials LLLP — Blackfoot, Idaho, United States
• Northwest Clinical Trials — Boise, Idaho, United States
• Rocky Mountain Diabetes and Osteoporosis Center — Idaho Falls, Idaho, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• Iderc, P.L.C. — West Des Moines, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Cotton O'Neil Diabetes and Endocrinology Center — Kansas City, Kansas, United States
• Palm Research Center — Las Vegas, Nevada, United States
• Palm Research Center — Las Vegas, Nevada, United States
• Manhattan Medical Research — New York, New York, United States
• Aventiv Research — Columbus, Ohio, United States
• Heritage Valley Medical Group, Inc. — Beaver, Pennsylvania, United States
• Partners in Nephrology & Endocrinology — Pittsburgh, Pennsylvania, United States
• Valley Research — Fresno, California, United States

Full record on ClinicalTrials.gov

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