NCT01969747

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1 year until next milestone

Results Posted

Study results publicly available

April 8, 2015

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

5 months

First QC Date

October 22, 2013

Results QC Date

March 23, 2015

Last Update Submit

April 6, 2015

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (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

    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)

Study Arms (4)

Empagliflozin low

EXPERIMENTAL

Empagliflozin low once daily

Drug: Empagliflozin medium placeboDrug: Empagliflozin high placeboDrug: Empagliflozin low

Empagliflozin medium

EXPERIMENTAL

Empagliflozin medium once daily

Drug: Empagliflozin low placeboDrug: Empagliflozin high placeboDrug: Empagliflozin medium

Empagliflozin high

EXPERIMENTAL

Empagliflozin high once daily

Drug: Empagliflozin medium placeboDrug: Empagliflozin low placeboDrug: Empagliflozin high

Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: Empagliflozin low placeboDrug: Empagliflozin high placeboDrug: Empagliflozin medium placebo

Interventions

Empagliflozin medium placeboDRUG

Empagliflozin medium placebo

Empagliflozin high
Empagliflozin low placeboDRUG

Empagliflozin low placebo

Empagliflozin medium
Empagliflozin high placeboDRUG

Empagliflozin high placebo

Empagliflozin medium
Empagliflozin mediumDRUG

Empagliflozin medium

Empagliflozin medium
Empagliflozin lowDRUG

Empagliflozin low

Empagliflozin low
Empagliflozin highDRUG

Empagliflozin high

Empagliflozin high

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

1245.78.43001 Boehringer Ingelheim Investigational Site

Graz, Austria

Location

1245.78.49001 Boehringer Ingelheim Investigational Site

Neuss, Germany

Location

Related Publications (2)

  • 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.

    PMID: 27929674DERIVED

  • 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.

    PMID: 24746173DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

October 25, 2013

Study Start

November 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 8, 2015

Results First Posted

April 8, 2015

Record last verified: 2015-04

Locations

DE(1)AU(1)