Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1

In brief

Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week follow-up period.

Key facts

Study ID

NCT02414958

Run by

Boehringer Ingelheim

People needed

730

Starts

2015-06-30

Expected to finish

2017-10-23

Last updated by the study team

2019-01-03

Who can join

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

You may qualify if…

• Male or female patient receiving insulin for the treatment of documented diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 1 year at the time of Visit 1
• Fasting C-peptide value of < 0.7 ng/mL (0.23 nmol/L) at Visit 2 measured by the central laboratory
• Use of, and be willing, based on the Investigator's judgement, to continue throughout the duration of the trial, either:
• Multiple Daily Injections (MDI) of insulin consisting of at least one basal insulin injection and at least three daily bolus injections OR
• Continuous Subcutaneous Insulin Infusion (CSII) of any insulin type, with at least 5 months experience of using CSII prior to Visit 1
• HbA1c >/= 7.5% and </= 10.0% at Visit 5 measured by the central laboratory
• Age >/= 18 years at Visit 1
• Additional inclusion criteria may apply

You may not qualify if…

• History of Type 2 Diabetes Mellitus (T2DM), maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis
• Pancreas, pancreatic islet cells or renal transplant recipient
• T1DM treatment with any other antihyperglycaemic drug (e.g. metformin, alpha-glucosidase inhibitors, Glucagon-like-peptide 1 (GLP-1) analogues, Sodium-Glucose Co-Transporter (SGLT-2) inhibitors, pramlintide, inhaled insulin, pre-mixed insulins etc.) except subcutaneous basal and bolus insulin within 3 months prior to Visit 1
• Occurrence of severe hypoglycaemia involving coma/unconsciousness and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to Visit 1 and until randomisation
• Occurence of Diabetic Ketoacidosis (DKA) within 3 months prior to Visit 1 and until randomisation
• Additional exclusion criteria may apply

Where it is running

• Diabetes/Lipid Management and Research Center — Huntington Beach, California, United States
• National Research Institute — Los Angeles, California, United States
• Mills-Peninsula Health Services — San Mateo, California, United States
• Metabolic Institute of America — Tarzana, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• Creekside Endocrine Associates, PC — Denver, Colorado, United States
• The Center for Diabetes and Endocrine Care — Fort Lauderdale, Florida, United States
• East Coast Institute for Research, LLC — Jacksonville, Florida, United States
• Baptist Diabetes Associates, PA — Miami, Florida, United States
• Physicians Research Associates, LLC — Lawrenceville, Georgia, United States
• Endocrine Research Solutions, Inc. — Roswell, Georgia, United States
• Rocky Mountain Diabetes and Osteoporosis Center — Idaho Falls, Idaho, United States
• Northwest Endo Diabetes Research, LLC — Arlington Heights, Illinois, United States
• Midwest Endocrinology — Crystal Lake, Illinois, United States
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
• Diabetes anddocrine Associates, PC — Omaha, Nebraska, United States
• Desert Endocrinology Clinical Research Center — Henderson, Nevada, United States
• Palm Research Center — Las Vegas, Nevada, United States
• Southern New Hampshire Diabetes and Endocrinology — Nashua, New Hampshire, United States
• Albany Medical Center / Albany Medical College — Albany, New York, United States
• University Physicians Group Research Division — Staten Island, New York, United States
• Diabetes and Endocrinology Consultants, PC — Morehead City, North Carolina, United States
• The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital — Cincinnati, Ohio, United States
• Diabetes and Obesity Clinical Trials Center — Nashville, Tennessee, United States
• AMCR Institute, Inc. — Escondido, California, United States

Full record on ClinicalTrials.gov

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