A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: empagliflozin (low dose qd); Drug: Empagliflozin (high dose qd); Drug: empagliflozin (low dose bid); Drug: empagliflozin (high dose bid); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01649297

1276.10

2012-000905-53 (EudraCT Number)

Details and patient eligibility

About

The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.

Enrollment: 983 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. confirmed diagnosis of T2DM
2. Glycated hemoglobin (HbA1c) >=7.0 and <=10/0% at Visit 1
3. Metformin therapy (at least 1500 mg/day, BID)
4. age>=18 at Visit 1
5. body mass index <=45 kg/m2

Exclusion criteria

1. estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) screening and/or run-in
2. a confirmed glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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983 participants in 5 patient groups, including a placebo group

empagliflozin (high dose qd)

Experimental group

Description:

Patients receive Empagliflozin high dose once daily

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Empagliflozin (high dose qd)

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

empagliflozin (high dose bid)

Experimental group

Description:

Patients receive Empagliflozin high dose split twice daily

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: empagliflozin (high dose bid)

Drug: Placebo

empagliflozin (low dose qd)

Experimental group

Description:

Patients receive Empagliflozin low dose once daily

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: empagliflozin (low dose qd)

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

empagliflozin (low dose bid)

Experimental group

Description:

Patients receive Empagliflozin low dose split twice daily

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: empagliflozin (low dose bid)

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Patients receive placebo matching Empagliflozin

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo