Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes

Conditions

• Diabetes Mellitus, Type 2
• Hyperglycemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Metformin 500 mg bid — DRUG
  Metformin 500 mg twice daily
• Metformin 1000 mg bid — DRUG
  Metformin 1000 mg twice daily
• Empagliflozin low dose qd — DRUG
  Empagliflozin low dose once daily
• Empagliflozin high dose qd — DRUG
  Empagliflozin high dose once daily
• Empagliflozin low dose bid — DRUG
  Empagliflozin low dose split twice daily
• Metformin 500 mg bid — DRUG
  Metformin 500 mg twice daily
• Empagliflozin high dose bid — DRUG
  Empagliflozin high dose split twice daily
• Empagliflozin low dose bid — DRUG
  Empagliflozin low dose split twice daily
• Metformin 1000 mg bid — DRUG
  Metformin 1000 mg twice daily
• Metformin 500 mg bid — DRUG
  Metformin 500 mg twice daily
• Metformin 1000 mg bid — DRUG
  Metformin 1000 mg twice daily
• Empagliflozin high dose bid — DRUG
  Empagliflozin high dose split twice daily
• Metformin 1000 mg bid — DRUG
  Metformin 1000 mg twice daily
• Empagliflozin high dose bid — DRUG
  Empagliflozin high dose split twice daily

Study Details

This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

Key Dates

Start date

Oct 31, 2012

Status verified

Jan 2016

Primary completion

Nov 30, 2014

Completion

Dec 31, 2014

Study Design

Enrollment

1,413 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Empagliflozin low dose qd
  Empagliflozin low dose once daily
• Experimental: Empagliflozin high dose qd
  Empagliflozin high dose once daily
• Experimental: OL empa high dose + met 1000 mg bid
  Open label empagliflozin high dose split twice daily + metformin 1000 mg twice daily - Patients are no longer enrolled into this arm because of change in the inclusion criteria in protocol version 2.0 all patients are now enrolled into remaining double-blind arms. Patients already enrolled in the open-label arm according to protocol version 1.0 can complete the study.
• Experimental: Empagliflozin low dose + met 500 mg bid
  Empagliflozin low dose split twice daily + metformin 500 mg twice daily
• Experimental: Empagliflozin low dose + met 1000 mg bid
  Empagliflozin low dose split twice daily + metformin 1000 mg twice daily
• Experimental: Empagliflozin high dose + met 500 mg bid
  Empagliflozin high dose split twice daily + metformin 500 mg twice daily
• Experimental: Empagliflozin high dose + met 1000mg bid
  Empagliflozin high dose split twice daily + metformin 1000 mg twice daily
• Experimental: Metformin 500 mg bid
  Metformin 500 mg twice daily
• Experimental: Metformin 1000 mg bid
  Metformin 1000 mg twice daily

Primary Outcome Measure

HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24 [ Time Frame: baseline and 24 weeks ]

Locations (41)

Find similar trials in Birmingham, AL

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