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Trial record 6 of 76 for:    Empagliflozin type 1 diabetes

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02580591
First received: October 19, 2015
Last updated: May 2, 2017
Last verified: May 2017
  Purpose
The study will investigate the efficacy, safety, tolerability and 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 Intervention Phase
Diabetes Mellitus, Type 1 Drug: Empagliflozin Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: 26 weeks ]

Secondary Outcome Measures:
  • Change from baseline in body weight [ Time Frame: 26 weeks ]
  • Change from baseline in total daily insulin dose [ Time Frame: 26 weeks ]
  • Incidence rate of symptomatic hypoglycaemic AEs with confirmed plasma glucose < 54 mg/dL (< 3.0 mmol/L) and/or severe hypoglycaemic AEs per patient-year [ Time Frame: Week 5 to Week 26 ]
  • Incidence rate of symptomatic hypoglycaemic AEs with confirmed plasma glucose < 54 mg/dL (< 3.0 mmol/L) and/or severe hypoglycaemic AEs per patient-year [ Time Frame: Week 1 to Week 26 ]
  • Change from baseline in systolic blood pressure (SBP) [ Time Frame: 26 weeks ]
  • Change from baseline in diastolic blood pressure (DBP) [ Time Frame: 26 weeks ]

Estimated Enrollment: 960
Actual Study Start Date: October 12, 2015
Estimated Study Completion Date: September 22, 2017
Estimated Primary Completion Date: September 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02580591

  Show 179 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02580591     History of Changes
Other Study ID Numbers: 1245.72
2014-005256-26 ( EudraCT Number )
Study First Received: October 19, 2015
Last Updated: May 2, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017