Diabetes Mellitus, Type 2Phase 3NCT01984606
Efficacy and Safety of Empagliflozin Versus Sitagliptin in Patients With Type 2 Diabetes
A Phase 3 study testing Empagliflozin and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim.
Trial summary
The purpose of this study is to assess safety and efficacy of empagliflozin compared to sitagliptin in patients with type 2 diabetes mellitus who are treatment-naive or on treatment with metformin and have insufficient glycaemic control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Empagliflozin and Sitagliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Feb 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes mellitus.
- Male and female patients on diet and exercise regimen who are:
- Treatment-naïve, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomisation.
- or
- Pre-treated with immediate release metformin unchanged for 10 weeks prior to randomisation. Minimum dose for metformin: >=1500 mg/day or maximum tolerated dose or maximum dose according to local label.
- HbA1c of >= 7.5 % and <= 10.5 % at Visit 1 and 3.
- Age >= 18 yrs.
Who cannot join
- Uncontrolled hyperglycaemia with a glucose level >270 mg/dL (>15 mmol/L) after an overnight fast during dose stabilisation (if applicable) and/or placebo run-in.
- Any other antidiabetic drug within 12 weeks prior to randomisation (applicable to treatment-naïve patients).
- Any other antidiabetic drug within 10 weeks prior to randomisation except metformin (applicable to patients on background treatment with metformin).
- Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent.
- Indication of liver disease.
- Moderate to severe renal impairment.
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- Bariatric surgery within the past two years.
- Treatment with anti-obesity drugs 3 months prior to informed consent.
- Current treatment with systemic steroids at time of informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus.
About this study
Official title: A Phase IIIb Randomised, Double-blind, Active-controlled, Parallel Group, Efficacy and Safety Study of Once Daily Oral Administration of Empagliflozin 25 mg Compared to Sitagliptin 100 mg During 52 Weeks in Type 2 Diabetes Mellitus Patients Who Are Treatment-naïve or on Treatment With Metformin With Insufficient Glycaemic Control
The purpose of this study is to assess safety and efficacy of empagliflozin compared to sitagliptin in patients with type 2 diabetes mellitus who are treatment-naive or on treatment with metformin and have insufficient glycaemic control. The study will assess non-inferiority of empagliflozin to sitagliptin with regards to HbA1c.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Empagliflozin, Placebo, Sitagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Empagliflozin once daily
PlaceboDrug
Placebo matching empagliflozin
SitagliptinDrug
Sitagliptin once daily
PlaceboDrug
Placebo matching sitagliptin
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | Empagliflozin once daily Receives: Drug: Empagliflozin; Drug: Placebo |
| Sitagliptin | Active comparator | Sitagliptin once daily Receives: Drug: Sitagliptin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in HbA1c after 52 weeks of treatment.
Measured: Baseline and week 52
Secondary outcomes (4)
The change in bodyweight (kg) from baseline after 52 weeks of treatment
Measured: Baseline and week 52
The change in Systolic Blood Pressure (SBP) from baseline after 52 weeks of treatment
Measured: Baseline and week 52
The coefficient of durability of HbA1c response between 24 weeks and 52 weeks of treatment
Measured: Week 24 and week 52
The change in Diastolic Blood Pressure (DBP) from baseline after 52 weeks of treatment
Measured: Baseline and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startJan 2015
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 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
- NCT01984606
- Sponsor's protocol ID
- 1245.22
- Other IDs
- 2013-000060-29
- Status last verified
- Oct 2014
- First submitted
- 8 Nov 2013
- Last updated
- 27 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb Randomised, Double-blind, Active-controlled, Parallel Group, Efficacy and Safety Study of Once Daily Oral Administration of Empagliflozin 25 mg Compared to Sitagliptin 100 mg During 52 Weeks in Type 2 Diabetes Mellitus Patients Who Are Treatment-naïve or on Treatment With Metformin With Insufficient Glycaemic Control
- ClinicalTrials.gov ID
- NCT01984606
- Acronym / sponsor ID
- 1245.22
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Jan 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess safety and efficacy of empagliflozin compared to sitagliptin in patients with type 2 diabetes mellitus who are treatment-naive or on treatment with metformin and have insufficient glycaemic control. The study will assess non-inferiority of empagliflozin to sitagliptin with regards to HbA1c.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: Empagliflozin, Drug: PlaceboEmpagliflozin once daily |
| Sitagliptin | Active comparator | Drug: Sitagliptin, Drug: PlaceboSitagliptin once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of type 2 diabetes mellitus.
- Male and female patients on diet and exercise regimen who are:
- Treatment-naïve, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomisation.
- or
- Pre-treated with immediate release metformin unchanged for 10 weeks prior to randomisation. Minimum dose for metformin: >=1500 mg/day or maximum tolerated dose or maximum dose according to local label.
Key exclusion criteria (9 listed)
- Uncontrolled hyperglycaemia with a glucose level >270 mg/dL (>15 mmol/L) after an overnight fast during dose stabilisation (if applicable) and/or placebo run-in.
- Any other antidiabetic drug within 12 weeks prior to randomisation (applicable to treatment-naïve patients).
- Any other antidiabetic drug within 10 weeks prior to randomisation except metformin (applicable to patients on background treatment with metformin).
- Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent.
- Indication of liver disease.
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 |
|---|---|---|
| EmpagliflozinEmpagliflozin once daily | Drug | Empagliflozin |
| PlaceboPlacebo matching empagliflozin | Drug | Empagliflozin |
| SitagliptinSitagliptin once daily | Drug | Sitagliptin |
| PlaceboPlacebo matching sitagliptin | Drug | Sitagliptin |
Primary outcome
The change from baseline in HbA1c after 52 weeks of treatment.
Time frame: Baseline and week 52
4 secondary outcomes
The change in bodyweight (kg) from baseline after 52 weeks of treatment
Time frame: Baseline and week 52
The change in Systolic Blood Pressure (SBP) from baseline after 52 weeks of treatment
Time frame: Baseline and week 52
The coefficient of durability of HbA1c response between 24 weeks and 52 weeks of treatment
Time frame: Week 24 and week 52
The change in Diastolic Blood Pressure (DBP) from baseline after 52 weeks of treatment
Time frame: Baseline and week 52
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Empagliflozin and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim.
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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The change from baseline in HbA1c after 52 weeks of treatment. (time frame: Baseline and week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2014.