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

Conditions

• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Patients receive placebo matching empagliflozin (low dose qd)
• Placebo — DRUG
  Patients receive placebo matching empagliflozin (low dose bid)
• Placebo — DRUG
  Patients receive placebo matching Empagliflozin (high dose qd)
• Placebo — DRUG
  Patients receive placebo matching Empagliflozin (high dose qd)
• Placebo — DRUG
  Patients receive placebo matching Empagliflozin (high dose qd)
• empagliflozin (low dose qd) — DRUG
  Patients receive Empagliflozin low dose once daily
• Placebo — DRUG
  Patients receive placebo matching empagliflozin (low dose qd)
• Placebo — DRUG
  Patients receive placebo matching empagliflozin (low dose bid)
• Placebo — DRUG
  Patients receive placebo matching Empagliflozin (high dose bid)
• Placebo — DRUG
  Patients receive placebo matching Empagliflozin (high dose bid)
• Placebo — DRUG
  Patients receive placebo matching empagliflozin (low dose qd)
• Placebo — DRUG
  Patients receive placebo matching empagliflozin (low dose bid)
• Placebo — DRUG
  Patients receive placebo matching Empagliflozin (high dose bid)
• Placebo — DRUG
  Patients receive placebo matching empagliflozin (low dose qd)
• Placebo — DRUG
  Patients receive placebo matching empagliflozin (low dose bid)
• Placebo — DRUG
  Patients receive placebo matching Empagliflozin (high dose bid)
• Empagliflozin (high dose qd) — DRUG
  Patients receive Empagliflozin high dose once daily
• empagliflozin (high dose bid) — DRUG
  Patients receive Empagliflozin high dose split twice daily
• Placebo — DRUG
  Patients receive placebo matching Empagliflozin (high dose qd)
• empagliflozin (low dose bid) — DRUG
  Patients receive Empagliflozin low dose split twice daily

Study Details

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.

Key Dates

Start date

Oct 31, 2012

Status verified

Jun 2015

Primary completion

Dec 31, 2013

Completion

Dec 31, 2013

Study Design

Enrollment

983 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: empagliflozin (high dose qd)
  Patients receive Empagliflozin high dose once daily
• Experimental: empagliflozin (high dose bid)
  Patients receive Empagliflozin high dose split twice daily
• Experimental: empagliflozin (low dose qd)
  Patients receive Empagliflozin low dose once daily
• Experimental: empagliflozin (low dose bid)
  Patients receive Empagliflozin low dose split twice daily
• Placebo Comparator: Placebo
  Patients receive placebo matching Empagliflozin

Primary Outcome Measure

HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16 [ Time Frame: Baseline and 16 weeks ]

Locations (39)

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