Overview
Efficacy and Safety of Empagliflozin Versus Sitagliptin in Patients With Type 2 Diabetes
Status:
Withdrawn
Withdrawn
Trial end date:
2017-02-01
2017-02-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Boehringer IngelheimCollaborator:
Eli Lilly and CompanyTreatments:
Empagliflozin
Sitagliptin Phosphate
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.