- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01969747
Empagliflozin add-on to Insulin in Type 1 Diabetes Mellitus Over 28 Days
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Empagliflozin medium placebo
Empagliflozin high placebo
Empagliflozin low placebo
|
EXPERIMENTAL: Empagliflozin low
Empagliflozin low once daily
|
Empagliflozin medium placebo
Empagliflozin high placebo
Empagliflozin low
|
EXPERIMENTAL: Empagliflozin medium
Empagliflozin medium once daily
|
Empagliflozin high placebo
Empagliflozin low placebo
Empagliflozin medium
|
EXPERIMENTAL: Empagliflozin high
Empagliflozin high once daily
|
Empagliflozin medium placebo
Empagliflozin low placebo
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
Sponsor
Collaborators
Publications and helpful links
General Publications
- Famulla S, Pieber TR, Eilbracht J, Neubacher D, Soleymanlou N, Woerle HJ, Broedl UC, Kaspers S. Glucose Exposure and Variability with Empagliflozin as Adjunct to Insulin in Patients with Type 1 Diabetes: Continuous Glucose Monitoring Data from a 4-Week, Randomized, Placebo-Controlled Trial (EASE-1). Diabetes Technol Ther. 2017 Jan;19(1):49-60. doi: 10.1089/dia.2016.0261. Epub 2016 Dec 8.
- Lamos EM, Younk LM, Davis SN. Empagliflozin, a sodium glucose co-transporter 2 inhibitor, in the treatment of type 1 diabetes. Expert Opin Investig Drugs. 2014 Jun;23(6):875-82. doi: 10.1517/13543784.2014.909407. Epub 2014 Apr 19.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Sodium-Glucose Transporter 2 Inhibitors
- Empagliflozin
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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