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

Boehringer Ingelheim

Status and phase: Withdrawn; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Sitagliptin; Drug: Placebo; Drug: Empagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01984606

2013-000060-29 (EudraCT Number)

1245.22

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Empagliflozin

Experimental group

Description:

Empagliflozin once daily

Treatment:

Drug: Empagliflozin

Drug: Placebo

Drug: Placebo

Sitagliptin

Active Comparator group

Description:

Sitagliptin once daily

Treatment:

Drug: Placebo

Drug: Sitagliptin

Drug: Placebo