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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:11/4/2018
Start Date:December 22, 2015
End Date:September 20, 2017

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A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy, Safety and Tolerability Trial of Once Daily, Oral Doses of Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-3)

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


Inclusion criteria:

- 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

Exclusion criteria:

- 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
We found this trial at
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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8042 Wurzbach Road
San Antonio, Texas 78229
210-949-0807
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Arlington Heights, Illinois 60005
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Atlanta, Georgia 30309
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
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655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
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Baltimore, Maryland 21204
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Chattanooga, Tennessee 37403
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Chesapeake, Virginia 23321
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35 Gordon Street
Coffs Harbour, New South Wales 2450
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Fresno, California 93720
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Las Vegas, Nevada 89102
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Morehead City, North Carolina 28557
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New Port Richey, Florida 34652
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Oakland, California 94612
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Oklahoma City, Oklahoma 73103
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224 Alexander Street
Rochester, New York 14607
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1050 Eagles Landing Parkway
Stockbridge, Georgia 30281
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