Efficacy and Safety of Empagliflozin Versus Sitagliptin in Patients With Type 2 Diabetes

Launched by BOEHRINGER INGELHEIM · Nov 8, 2013

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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.