Diabetes Mellitus, Type 1Phase 2NCT01969747
Empagliflozin add-on to Insulin in Type 1 Diabetes Mellitus Over 28 Days
A Phase 2 study testing Empagliflozin medium and Empagliflozin low in people with Diabetes Mellitus, Type 1, run by Boehringer Ingelheim at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Empagliflozin medium and Empagliflozin low
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2013to Apr 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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)
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Empagliflozin medium placebo, Empagliflozin low placebo, Empagliflozin high placebo, Empagliflozin medium, Empagliflozin low
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin medium placeboDrug
Empagliflozin medium placebo
Empagliflozin low placeboDrug
Empagliflozin low placebo
Empagliflozin low placeboDrug
Empagliflozin low placebo
Empagliflozin high placeboDrug
Empagliflozin high placebo
Empagliflozin mediumDrug
Empagliflozin medium
Empagliflozin medium placeboDrug
Empagliflozin medium placebo
Empagliflozin high placeboDrug
Empagliflozin high placebo
Empagliflozin high placeboDrug
Empagliflozin high placebo
Empagliflozin medium placeboDrug
Empagliflozin medium placebo
Empagliflozin low placeboDrug
Empagliflozin low placebo
Empagliflozin lowDrug
Empagliflozin low
Empagliflozin highDrug
Empagliflozin high
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin low | Experimental | Empagliflozin low once daily Receives: Drug: Empagliflozin medium placebo; Drug: Empagliflozin high placebo; Drug: Empagliflozin low |
| Empagliflozin medium | Experimental | Empagliflozin medium once daily Receives: Drug: Empagliflozin low placebo; Drug: Empagliflozin high placebo; Drug: Empagliflozin medium |
| Empagliflozin high | Experimental | Empagliflozin high once daily Receives: Drug: Empagliflozin medium placebo; Drug: Empagliflozin low placebo; Drug: Empagliflozin high |
| Placebo | Placebo comparator | Placebo once daily Receives: Drug: Empagliflozin low placebo; Drug: Empagliflozin high placebo; Drug: Empagliflozin medium placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (Day -1) and 7 days after first drug administration (Day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969747
- Sponsor's protocol ID
- 1245.78
- Other IDs
- 2011-004354-25
- Status last verified
- Apr 2015
- First submitted
- 22 Oct 2013
- Last updated
- 8 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
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.
PubMed 27929674Lamos 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.
PubMed 24746173
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01969747
- Acronym / sponsor ID
- 1245.78
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Posted 8 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin low | Experimental | Drug: Empagliflozin medium placebo, Drug: Empagliflozin high placebo, Drug: Empagliflozin lowEmpagliflozin low once daily |
| Empagliflozin medium | Experimental | Drug: Empagliflozin low placebo, Drug: Empagliflozin high placebo, Drug: Empagliflozin mediumEmpagliflozin medium once daily |
| Empagliflozin high | Experimental | Drug: Empagliflozin medium placebo, Drug: Empagliflozin low placebo, Drug: Empagliflozin highEmpagliflozin high once daily |
| Placebo | Placebo comparator | Drug: Empagliflozin low placebo, Drug: Empagliflozin high placebo, Drug: Empagliflozin medium placeboPlacebo once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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%
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin medium placeboEmpagliflozin medium placebo | Drug | Empagliflozin high |
| Empagliflozin low placeboEmpagliflozin low placebo | Drug | Empagliflozin medium |
| Empagliflozin low placeboEmpagliflozin low placebo | Drug | Placebo |
| Empagliflozin high placeboEmpagliflozin high placebo | Drug | Empagliflozin medium |
| Empagliflozin mediumEmpagliflozin medium | Drug | Empagliflozin medium |
| Empagliflozin medium placeboEmpagliflozin medium placebo | Drug | Empagliflozin low |
| Empagliflozin high placeboEmpagliflozin high placebo | Drug | Empagliflozin low |
| Empagliflozin high placeboEmpagliflozin high placebo | Drug | Placebo |
| Empagliflozin medium placeboEmpagliflozin medium placebo | Drug | Placebo |
| Empagliflozin low placeboEmpagliflozin low placebo | Drug | Empagliflozin high |
| Empagliflozin lowEmpagliflozin low | Drug | Empagliflozin low |
| Empagliflozin highEmpagliflozin high | Drug | Empagliflozin high |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27929674Famulla 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.
- Derived from this study: PubMed 24746173Lamos 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin medium and Empagliflozin low in people with Diabetes Mellitus, Type 1, run by Boehringer Ingelheim at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01969747, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.