A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy

Completed · Phase 3

Conditions studied: Type 1 Diabetes Mellitus

In brief

The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).

Key facts

Study ID

NCT03830281

Run by

Eli Lilly and Company

People needed

471

Starts

2019-02-14

Expected to finish

2020-01-06

Last updated by the study team

2021-01-22

Who can join

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

You may qualify if…

• Have been diagnosed with T1D and continuously using insulin for at least 1 year
• Have been using CSII therapy for a minimum of 6 months
• Currently treated with <100 Units of one of following rapid-acting analog insulin via CSII for at least the past 30 days: insulin lispro U-100, insulin aspart, fast-acting insulin aspart, insulin glulisine
• Must be using a MiniMed 530G (US), Paradigm Revel (US), or MiniMed 630G (US and Canada), MiniMed 640G or Paradigm Veo (select countries outside the US), insulin pump for at least the past 90 days

You may not qualify if…

• Have hypoglycemia unawareness
• Have had more than 1 episode of severe hypoglycemia within 6 months prior to screening
• Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening

Where it is running

• Valley Research — Fresno, California, United States
• Marin Endocrine Associates — Greenbrae, California, United States
• Diabetes and Endocrine Associates — La Mesa, California, United States
• First Valley Medical Group — Lancaster, California, United States
• Center of Excellence in Diabetes & Endocrinology — Sacramento, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• Coastal Metabolic Research Centre — Ventura, California, United States
• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States
• ALL Medical Research, LLC — Cooper City, 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
• Endocrine Research Solutions, Inc. — Roswell, Georgia, United States
• East West Medical Institute — Honolulu, Hawaii, United States
• Rocky Mountain Diabetes and Osteoporosis Center — Idaho Falls, Idaho, United States
• Northwestern Feinberg School of Medicine — Chicago, Illinois, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• Iderc, P.L.C. — West Des Moines, Iowa, United States
• Kentucky Diabetes Endocrinology Center — Lexington, Kentucky, United States
• Endocrine and Metabolic Consultants — Rockville, Maryland, United States
• Palm Research Center — Las Vegas, Nevada, United States
• Palm Research Center — Las Vegas, Nevada, United States
• Southern New Hampshire Diabetes and Endocrinology — Nashua, New Hampshire, United States
• Physicians East — Greenville, North Carolina, United States
• John Muir Physician Network Clinical Research Center — Concord, California, United States

Full record on ClinicalTrials.gov

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