Clinical trial NCT01984606: Efficacy and Safety of Empagliflozin Versus Sitagliptin in Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2013-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

Inclusion criteria:

* 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.

Exclusion criteria:

* 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.

Primary outcomes:
measure: The change from baseline in HbA1c after 52 weeks of treatment.
timeFrame: Baseline and week 52
Secondary outcomes:
measure: The change in bodyweight (kg) from baseline after 52 weeks of treatment
timeFrame: Baseline and week 52
measure: The change in Systolic Blood Pressure (SBP) from baseline after 52 weeks of treatment
timeFrame: Baseline and week 52
measure: The coefficient of durability of HbA1c response between 24 weeks and 52 weeks of treatment
timeFrame: Week 24 and week 52
measure: The change in Diastolic Blood Pressure (DBP) from baseline after 52 weeks of treatment
timeFrame: Baseline and week 52
Other outcomes:
Locations:
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: