Efficacy and Safety of Empagliflozin Versus Sitagliptin in Patients With Type 2 Diabetes
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
2 other identifiers
interventional
N/A
0 countries
N/A
Brief 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. The study will assess non-inferiority of empagliflozin to sitagliptin with regards to HbA1c.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2015
Typical duration for phase_3 diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2013
CompletedFirst Posted
Study publicly available on registry
November 14, 2013
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedOctober 27, 2014
October 1, 2014
2.1 years
November 8, 2013
October 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
The change from baseline in HbA1c after 52 weeks of treatment.
Baseline and week 52
Secondary Outcomes (4)
The change in bodyweight (kg) from baseline after 52 weeks of treatment
Baseline and week 52
The change in Systolic Blood Pressure (SBP) from baseline after 52 weeks of treatment
Baseline and week 52
The coefficient of durability of HbA1c response between 24 weeks and 52 weeks of treatment
Week 24 and week 52
The change in Diastolic Blood Pressure (DBP) from baseline after 52 weeks of treatment
Baseline and week 52
Study Arms (2)
Empagliflozin
EXPERIMENTALEmpagliflozin once daily
Sitagliptin
ACTIVE COMPARATORSitagliptin once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boehringer Ingelheimlead
- Eli Lilly and Companycollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2013
First Posted
November 14, 2013
Study Start
January 1, 2015
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
October 27, 2014
Record last verified: 2014-10