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

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2, Hyperglycemia

In brief

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 facts

Study ID: NCT01719003
Run by: Boehringer Ingelheim
People needed: 1413
Starts: 2012-10-01
Expected to finish: 2014-12-01
Last updated by the study team: 2016-02-19

Who can join

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

You may qualify if…

Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients on diet and exercise regimen who are drug-naive, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomization
HbA1c >=7.5% and <= 12% (>=58.5 mmol/mol and <=107.7 mmol/mol)
Body Mass Index (BMI) <= 45 kg/m2 at screening

You may not qualify if…

Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second laboratory measurement (not on the same day)
Any antidiabetic drug within 12 weeks prior to randomization
Impaired renal function, defined as estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) as determined during screening and/or run-in period
Contraindications to metformin according to the local label

Where it is running

1276.1.10019 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
1276.1.10044 Boehringer Ingelheim Investigational Site — Manley Hot Springs, Alaska, United States
1276.1.10010 Boehringer Ingelheim Investigational Site — Glendale, Arizona, United States
1276.1.10035 Boehringer Ingelheim Investigational Site — Searcy, Arkansas, United States
1276.1.10046 Boehringer Ingelheim Investigational Site — Chula Vista, California, United States
1276.1.10006 Boehringer Ingelheim Investigational Site — Huntington Beach, California, United States
1276.1.10043 Boehringer Ingelheim Investigational Site — La Mesa, California, United States
1276.1.10009 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
1276.1.10040 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
1276.1.10045 Boehringer Ingelheim Investigational Site — Oceanside, California, United States
1276.1.10042 Boehringer Ingelheim Investigational Site — Colorado Springs, Colorado, United States
1276.1.10001 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
1276.1.10003 Boehringer Ingelheim Investigational Site — Northglenn, Colorado, United States
1276.1.10026 Boehringer Ingelheim Investigational Site — Fort Lauderdale, Florida, United States
1276.1.10024 Boehringer Ingelheim Investigational Site — Oldsmar, Florida, United States
1276.1.10027 Boehringer Ingelheim Investigational Site — Port Orange, Florida, United States
1276.1.10023 Boehringer Ingelheim Investigational Site — Marietta, Georgia, United States
1276.1.10034 Boehringer Ingelheim Investigational Site — Evansville, Indiana, United States
1276.1.10032 Boehringer Ingelheim Investigational Site — Fall River, Massachusetts, United States
1276.1.10036 Boehringer Ingelheim Investigational Site — Bridgman, Michigan, United States
1276.1.10037 Boehringer Ingelheim Investigational Site — Hazelwood, Missouri, United States
1276.1.10007 Boehringer Ingelheim Investigational Site — Las Vegas, Nevada, United States
1276.1.10015 Boehringer Ingelheim Investigational Site — Union, New Jersey, United States
1276.1.10033 Boehringer Ingelheim Investigational Site — Asheboro, North Carolina, United States
1276.1.10014 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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