Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.

Key facts

Study ID

NCT01734785

Run by

Boehringer Ingelheim

People needed

607

Starts

2013-02-08

Expected to finish

2015-03-23

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of type 2 diabetes mellitus.
• Male and female patients on diet and exercise regimen, pre-treated with immediate release metformin for at least 12 weeks, and patients should be on a dose higher or equal to 1500 mg/day of metformin, or maximum tolerated dose, or maximum dose as per local label.
• HbA1c higher or equal to 8.0% and lower or equal to 10.5% at screening visit.
• Age 18 years or more at screening.
• Body Mass Index lower or equal to 45 kg/m2 at screening visit.
• Signed and dated written informed consent.

You may not qualify if…

• Uncontrolled hyperglycemia with glucose level above 270 mg/dl (above 15 mmol/dl) after an overnight fast.
• Use of any other antidiabetic drug (except metformin background therapy).
• Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent.
• Indication of liver disease.
• Impaired renal function.
• Gastrointestinal surgery.
• Treatment with anti-obesity drugs within 3 months prior to screening, or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight.
• Current treatment with systemic steroids at time of informed consent or uncontrolled endocrine disorder except type 2 diabetes mellitus.

Where it is running

• 1275.9.01009 Boehringer Ingelheim Investigational Site — Norwalk, California, United States
• 1275.9.01015 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 1275.9.01017 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 1275.9.01011 Boehringer Ingelheim Investigational Site — Northglenn, Colorado, United States
• 1275.9.01010 Boehringer Ingelheim Investigational Site — Coral Gables, Florida, United States
• 1275.9.01004 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1275.9.01006 Boehringer Ingelheim Investigational Site — Oldsmar, Florida, United States
• 1275.9.01001 Boehringer Ingelheim Investigational Site — Palm Coast, Florida, United States
• 1275.9.01027 Boehringer Ingelheim Investigational Site — Port Orange, Florida, United States
• 1275.9.01029 Boehringer Ingelheim Investigational Site — Blue Ridge, Georgia, United States
• 1275.9.01003 Boehringer Ingelheim Investigational Site — Marietta, Georgia, United States
• 1275.9.01022 Boehringer Ingelheim Investigational Site — Savannah, Georgia, United States
• 1275.9.01031 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 1275.9.01019 Boehringer Ingelheim Investigational Site — Methuen, Massachusetts, United States
• 1275.9.01024 Boehringer Ingelheim Investigational Site — Troy, Michigan, United States
• 1275.9.01023 Boehringer Ingelheim Investigational Site — St Louis, Missouri, United States
• 1275.9.01002 Boehringer Ingelheim Investigational Site — Omaha, Nebraska, United States
• 1275.9.01007 Boehringer Ingelheim Investigational Site — Newington, New Hampshire, United States
• 1275.9.01016 Boehringer Ingelheim Investigational Site — Asheboro, North Carolina, United States
• 1275.9.01025 Boehringer Ingelheim Investigational Site — Burlington, North Carolina, United States
• 1275.9.01014 Boehringer Ingelheim Investigational Site — Shelby, North Carolina, United States
• 1275.9.01028 Boehringer Ingelheim Investigational Site — Winston-Salem, North Carolina, United States
• 1275.9.01018 Boehringer Ingelheim Investigational Site — Dayton, Ohio, United States
• 1275.9.01005 Boehringer Ingelheim Investigational Site — Corvallis, Oregon, United States
• 1275.9.01013 Boehringer Ingelheim Investigational Site — Gulf Shores, Alabama, United States

Full record on ClinicalTrials.gov

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