Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1

In brief

The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin

Key facts

Study ID

NCT02580591

Run by

Boehringer Ingelheim

People needed

977

Starts

2015-12-22

Expected to finish

2017-09-20

Last updated by the study team

2018-11-02

Who can join

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

You may qualify if…

• Signed and dated written informed consent
• Male or female patient receiving insulin for the treatment of documented diagnosis of type 1 diabetes mellitus (T1DM) > 1 year
• C-peptide value of < 0.7 ng/mL
• Use of Multiple Daily Injections (MDI) of insulin or insulin pump user with total daily insulin >= 0.3 and <= 1.5 U/kg
• Glycated haemoglobin (HbA1c) >= 7.5% and <= 10.0%
• Good understanding of T1DM
• Age >= 18 years
• Body Mass Index (BMI) >= 18.5 kg/m2
• Estimated glomerular filtration rate >= 30 mL/min/1.73 m2
• Women of child-bearing potential must use highly effective methods of birth control
• Compliance with trial medication administration between 80% and 120% during placebo run-in period Further inclusion criteria apply

You may not qualify if…

• History of type 2 diabetes mellitus, 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 except subcutaneous basal and bolus insulin within last 3 months
• Occurrence of severe hypoglycaemia within last 3 months and until randomisation
• Occurence of diabetic ketoacidosis within 3 months prior to Visit 1 and until Visit 6
• Irregular sleep/wake cycle
• Acute coronary syndrome, stroke or Transient Ischaemic Attack (TIA) within last 3 months
• Severe gastroparesis
• Brittle diabetes
• Liver disease
• Eating disorders
• Treatment with anti-obesity drugs, weight-loss surgery or aggressive diet regimen
• Treatment with systemic corticosteroids
• Change in dose of thyroid hormones within last 6 weeks and until randomisation
• Cancer or treatment for cancer in the last five years
• Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells
• Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial
• Alcohol or drug abuse
• Intake of an investigational drug in another trial within last 30 days Further exclusion criteria apply

Where it is running

• John Muir Physician Network Clinical Research Center — Concord, California, United States
• Valley Research — Fresno, California, United States
• Marin Endocrine Care and Research — Greenbrae, California, United States
• Pacific Research Partners, LLC — Oakland, California, United States
• NorCal Endocrinology and Internal Medicine — San Ramon, California, United States
• William Sansum Diabetes Center — Santa Barbara, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• International Research Associates, LLC — Hialeah, Florida, United States
• Solutions Through Advanced Research, Inc. — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• Physicians Research Associates, LLC — Lawrenceville, Georgia, United States
• Sestron Clinical Research — Marietta, Georgia, United States
• Eagle's Landing Diabetes and Endocrinology — Stockbridge, Georgia, United States
• Northwest Endo Diabetes Research, LLC — Arlington Heights, Illinois, United States
• Kentucky Diabetes Endocrinology Center — Lexington, Kentucky, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• MODEL Clinical Research — Baltimore, Maryland, United States
• Clinical Research Consultants, LLC — Kansas City, Missouri, United States
• Desert Endocrinology Clinical Research Center — Henderson, Nevada, United States
• Palm Research Center — Las Vegas, Nevada, United States
• Endocrine-Diabetes Care and Resource Center — Rochester, New York, United States
• Endocrine Associates of Long Island, PC — Smithtown, New York, United States
• Healthscan Clinical Trials LLC — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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