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

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ClinicalTrials.gov Identifier: NCT02580591
Recruitment Status : Completed
First Posted : October 20, 2015
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Empagliflozin Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 977 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : December 22, 2015
Actual Primary Completion Date : September 12, 2017
Actual Study Completion Date : September 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Empagliflozin low dose Drug: Empagliflozin
Drug: Placebo
For blinding purposes
Experimental: Empagliflozin high dose Drug: Empagliflozin
Drug: Placebo
For blinding purposes
Experimental: Empagliflozin medium dose Drug: Empagliflozin
Drug: Placebo
For blinding purposes
Placebo Comparator: Placebo Drug: Placebo
For blinding purposes


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC]) [ Time Frame: Baseline to week 26 ]
    Change from baseline in Glycated hemoglobin (HbA1c) for full analysis set (FAS) (observed cases [OC]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.

  2. Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD)) [ Time Frame: Baseline to week 26 ]
    Change from baseline in Glycated hemoglobin (HbA1c) for modified intention-to-treat population set (mITT) (observed case - all data [OC-AD]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.


Secondary Outcome Measures :
  1. Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycemic Adverse Events (AEs) With Confirmed Plasma Glucose (PG) [ Time Frame: Week 5 to Week 26, Week 1 to Week 26 ]
    Rate per patient-year of investigator-reported symptomatic hypoglycemic adverse events (AEs) with confirmed plasma glucose (PG) <54 milligram per deciliter (mg/dL) (<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycemic AEs (i.e. all investigator-reported AEs that had confirmed PG <54 mg/dL [<3.0 mmol/L] with symptoms reported and all severe hypoglycemic events that were confirmed by adjudication) is presented for (i) From week 5 to 26 and (ii) From week 1 to 26. Least squares mean is actually an adjusted event rate. This is key secondary endpoints.

  2. Change From Baseline in Body Weight at Week 26 [ Time Frame: Baseline to week 26 ]
    Change from baseline in body weight is presented With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.

  3. Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26 [ Time Frame: Baseline to week 26 ]
    Change from baseline in Total daily insulin dose (TDID) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.

  4. Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26 [ Time Frame: Baseline to week 26 ]
    Change from baseline in Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580591


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] October 21, 2016
Statistical Analysis Plan  [PDF] October 11, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02580591    
Other Study ID Numbers: 1245.72
2014-005256-26 ( EudraCT Number )
First Posted: October 20, 2015    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Empagliflozin
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs