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

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ClinicalTrials.gov Identifier: NCT01969747
Recruitment Status : Completed
First Posted : October 25, 2013
Results First Posted : April 8, 2015
Last Update Posted : April 8, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Empagliflozin medium placebo Drug: Empagliflozin low placebo Drug: Empagliflozin high placebo Drug: Empagliflozin medium Drug: Empagliflozin low Drug: Empagliflozin high Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : November 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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 low placebo
Empagliflozin low placebo

Drug: Empagliflozin high placebo
Empagliflozin high 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

Placebo Comparator: Placebo
Placebo once daily
Drug: Empagliflozin low placebo
Empagliflozin low placebo

Drug: Empagliflozin high placebo
Empagliflozin high placebo

Drug: Empagliflozin medium placebo
Empagliflozin medium placebo




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years to 65 Years   (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 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

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): NCT01969747


Locations
Austria
1245.78.43001 Boehringer Ingelheim Investigational Site
Graz, Austria
Germany
1245.78.49001 Boehringer Ingelheim Investigational Site
Neuss, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01969747     History of Changes
Other Study ID Numbers: 1245.78
2011-004354-25 ( EudraCT Number: EudraCT )
First Posted: October 25, 2013    Key Record Dates
Results First Posted: April 8, 2015
Last Update Posted: April 8, 2015
Last Verified: April 2015

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