Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.

Key facts

Study ID

NCT01778049

Run by

Boehringer Ingelheim

People needed

708

Starts

2013-01-01

Expected to finish

2015-03-01

Last updated by the study team

2016-04-04

Who can join

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

You may qualify if…

• Signed and dated ICF (Informed Consent Form)
• Male or female on diet and exercise regime and on stable background metformin > or equal to 1500 mg or maximun dose according to local label
• HBA1c (Glicoslated Hemoglobin) > or equal to 8% and < or equal to 10.5 % at Visit 1
• HbA1c > or equal to 7 and < or equal to 10.5 at Visit 4
• Age > or equal to 18 years
• BMI (Body Mass Index) < or equal to 45

You may not qualify if…

• Uncontrolled hyperglycemia during open label period and placebo add on "run-in" period
• Use of any other antidiabetic
• Renal function below 60 ml/min/1.73 m2
• Antiobesity drugs or aggresive diets
• Gastorintestinal surgeries
• Current systemic steroids or uncontrolled endocrine disorders other than Diabetes Type 2
• Acute coronary syndrome and stroke within 3 months of informed consent
• Known allergies to DPP-IV (Dypeptidil Peptidase IV) or SGLT-2 (Sodium Glucose Transporter 2) inhibitors

Where it is running

• 1275.10.01008 Boehringer Ingelheim Investigational Site — Huntington Beach, California, United States
• 1275.10.01003 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 1275.10.01024 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 1275.10.01002 Boehringer Ingelheim Investigational Site — Sylmar, California, United States
• 1275.10.01011 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1275.10.01009 Boehringer Ingelheim Investigational Site — Orlando, Florida, United States
• 1275.10.01023 Boehringer Ingelheim Investigational Site — Oviedo, Florida, United States
• 1275.10.01006 Boehringer Ingelheim Investigational Site — Tamarac, Florida, United States
• 1275.10.01017 Boehringer Ingelheim Investigational Site — Conyers, Georgia, United States
• 1275.10.01016 Boehringer Ingelheim Investigational Site — Snellville, Georgia, United States
• 1275.10.01012 Boehringer Ingelheim Investigational Site — Avon, Indiana, United States
• 1275.10.01013 Boehringer Ingelheim Investigational Site — Muncie, Indiana, United States
• 1275.10.01010 Boehringer Ingelheim Investigational Site — Elkton, Maryland, United States
• 1275.10.01001 Boehringer Ingelheim Investigational Site — Stevensville, Michigan, United States
• 1275.10.01007 Boehringer Ingelheim Investigational Site — Salisbury, North Carolina, United States
• 1275.10.01005 Boehringer Ingelheim Investigational Site — Bismarck, North Dakota, United States
• 1275.10.01020 Boehringer Ingelheim Investigational Site — Oklahoma City, Oklahoma, United States
• 1275.10.01022 Boehringer Ingelheim Investigational Site — Pittsburgh, Pennsylvania, United States
• 1275.10.01021 Boehringer Ingelheim Investigational Site — Union, South Carolina, United States
• 1275.10.01014 Boehringer Ingelheim Investigational Site — North Richland Hills, Texas, United States
• 1275.10.01018 Boehringer Ingelheim Investigational Site — Draper, Utah, United States
• 1275.10.01015 Boehringer Ingelheim Investigational Site — Richmond, Virginia, United States
• 1275.10.01025 Boehringer Ingelheim Investigational Site — Virginia Beach, Virginia, United States
• 1275.10.54005 Boehringer Ingelheim Investigational Site — Caba, Argentina
• 1275.10.01019 Boehringer Ingelheim Investigational Site — Chino, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.