Empagliflozin add-on to Insulin in Type 1 Diabetes Mellitus Over 28 Days

April 6, 2015 updated by: Boehringer Ingelheim

A 28-day Randomised, Placebo-controlled, Double-blind Parallel Group Phase IIa Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once Daily Oral Doses of 2.5 mg, 10 mg, and 25 mg Empagliflozin as Adjunctive to Insulin in Patients With Type 1 Diabetes Mellitus (EASE-2)

Placebo-controlled, double blind (triple-dummy technique), randomised parallel design comparison of three oral doses (2.5 mg, 10 mg, and 25 mg) of empagliflozin in patients with T1DM as adjunctive therapy to insulin over 28 days. Patients will undergo a 14-day open-label placebo run-in period before randomisation. Background insulin therapy will be kept stable during the first 7 days of the treatment period and will be freely adjusted thereafter.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • 1245.78.43001 Boehringer Ingelheim Investigational Site
  • Germany
      • Neuss, Germany
        • 1245.78.49001 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Signed and dated written informed consent
  • Male or female patient receiving insulin for treatment of T1DM for at least 12 months
  • C-peptide < 1.5 ng/mL
  • Age 18 to 65 years
  • HbA1c of 7.5% to 10.5%
  • Multiple daily injections (MDI) of any type of insulin
  • Willing to follow an established and individualized carbohydrate counting method and an insulin administration algorithm
  • Body Mass Index of 18.5 to 35.0 kg/m2
  • Estimated glomerular filtration rate 60 to 150 mL/min/1.73 m²
  • Able and willing to perform study assessments according to investigator's judgement
  • Compliance with trial drug administration 80% to 120% during run-in period
  • Willing not to take any paracetamol containing drugs during the trial

Exclusion criteria:

  • Acute symptomatic urinary tract infection or genital infection, chronic or recurrent cystitis
  • 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
  • Type 1 diabetes mellitus treatment with any other antihyperglycaemic drug except insulin within last 3 months or history of clinically relevant hypersensitivity
  • Occurrence of hypoglycaemia that required hospitalization or treatment by an emergency physician or paramedic within last 3 months
  • Hypoglycaemia unawareness or frequent episodes of unexplained hypoglycaemia
  • Occurrence of diabetic ketoacidosis that required hospitalization or treatment by an emergency physician or paramedic within last 12 months
  • History of macrovascular disease including cardiovascular, cerebrovascular and peripheral artery disease
  • Autonomic neuropathy with gastroparesis
  • Brittle diabetes
  • Liver disease
  • Treatment with anti-obesity drugs, surgery or aggressive diet regimen leading to unstable body weight
  • Treatment with systemic corticosteroids
  • Change in dose of thyroid hormones within last 6 weeks or planned change or initiation of such a therapy
  • Medical history of cancer or treatment for cancer in the last five years
  • Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells
  • Alcohol or drug abuse that would interfere with trial participation or any ongoing clinical condition that would jeopardize patient's or site personnel's safety or study compliance
  • Intake of an investigational drug in another trial within last 30 days
  • Not able to understand and comply with study requirements
  • Pre-menopausal women who are nursing or pregnant or of child-bearing potential and are not practising an acceptable method of birth control

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo once daily
Drug: Empagliflozin medium placebo
Empagliflozin medium placebo
Drug: Empagliflozin high placebo
Empagliflozin high placebo
Drug: Empagliflozin low placebo
Empagliflozin low placebo
EXPERIMENTAL: Empagliflozin low
Empagliflozin low once daily
Drug: Empagliflozin medium placebo
Empagliflozin medium placebo
Drug: Empagliflozin high placebo
Empagliflozin high placebo
Drug: Empagliflozin low
Empagliflozin low
EXPERIMENTAL: Empagliflozin medium
Empagliflozin medium once daily
Drug: Empagliflozin high placebo
Empagliflozin high placebo
Drug: Empagliflozin low placebo
Empagliflozin low placebo
Drug: Empagliflozin medium
Empagliflozin medium
EXPERIMENTAL: Empagliflozin high
Empagliflozin high once daily
Drug: Empagliflozin medium placebo
Empagliflozin medium placebo
Drug: Empagliflozin low placebo
Empagliflozin low placebo
Drug: Empagliflozin high
Empagliflozin high

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in 24 h UGE (g/24 h) After Seven Days of Treatment With Empagliflozin 2.5 mg, 10 mg, or 25 mg, or Placebo
Time Frame: baseline (Day -1) and 7 days after first drug administration (Day 7)

Change of urinary glucose excretion (UGE) (g/24 h) from baseline (refers to the last measurement prior to the first intake of any randomised trial medication) after seven days of treatment with empagliflozin 2.5 mg, 10 mg, or 25 mg, or placebo.

The treatment effect was estimated on the basis of the least square mean treatment difference at Day 7 extracted from the primary analysis model.

The primary endpoint is exploratory.
baseline (Day -1) and 7 days after first drug administration (Day 7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

October 22, 2013

First Posted (ESTIMATE)

October 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1245.78
  • 2011-004354-25 (EUDRACT_NUMBER: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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