Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.

Key facts

Study ID

NCT01159600

Run by

Boehringer Ingelheim

People needed

1504

Starts

2010-07-01

Last updated by the study team

2014-06-17

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 a diet and exercise regimen who are pre-treated with immediate release metformin or immediate release metformin plus sulfonylurea (see below for minimum doses). The treatment regimen has to be unchanged for 12 weeks prior to randomisation.
• Minimum dose for metformin: > or = 1500 mg/day or maximum tolerated dose or maximum dose according to local label Minimum dose for sulfonylurea: > or = half of the maximal recommended dose or maximum tolerated dose or maximum dose according to local label
• HbA1c of > or = 7.0% and < or = 11% at Visit 1 (screening) in order to be eligible for randomised treatment HbA1c of > 11% at Visit 1 (screening) in order to be eligible for the open-label treatment arm (25 mg BI 10773)
• Age> or = 18
• Body Mass Index (BM)I < or = 45 kg/m2 (Body Mass Index) at Visit 1 (Screening)
• Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation

You may not qualify if…

• Uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
• Any other antidiabetic drug within 12 weeks prior to randomisation except those mentioned in inclusion criterion 2
• Myocardial infarction, stroke or transient ischemic attack (TIA) within 3 months prior to informed consent
• Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase
• Impaired renal function, defined as eGFR<30 ml/min (severe renal impairment) as determined during screening and/or run-in phase
• Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
• Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
• Contraindications to metformin and/or sulfonylurea according to the local label for those patients that enter the study with the respective background therapy
• Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia)
• Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent 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 change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except Typ 2 Diabetes
• Pre-menopausal women (last menstruation ¿ 1 year prior to informed consent) who:
• are nursing or pregnant or
• are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner
• Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
• Participation in another trial with an investigational drug within 30 days prior to informed consent
• Any other clinical condition that would jeopardize patients safety while participating in this clinical trial

Where it is running

• 1245.23.10046 Boehringer Ingelheim Investigational Site — Tempe, Arizona, United States
• 1245.23.10095 Boehringer Ingelheim Investigational Site — Huntington Park, California, United States
• 1245.23.10109 Boehringer Ingelheim Investigational Site — Huntington Park, California, United States
• 1245.23.10074 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1245.23.10149 Boehringer Ingelheim Investigational Site — Rancho Cucamonga, California, United States
• 1245.23.10127 Boehringer Ingelheim Investigational Site — Waterbury, Connecticut, United States
• 1245.23.10042 Boehringer Ingelheim Investigational Site — Fort Lauderdale, Florida, United States
• 1245.23.10133 Boehringer Ingelheim Investigational Site — Jupiter, Florida, United States
• 1245.23.10080 Boehringer Ingelheim Investigational Site — Decatur, Georgia, United States
• 1245.23.10001 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 1245.23.10159 Boehringer Ingelheim Investigational Site — Des Moines, Iowa, United States
• 1245.23.10117 Boehringer Ingelheim Investigational Site — Arkansas City, Kansas, United States
• 1245.23.10157 Boehringer Ingelheim Investigational Site — Newton, Kansas, United States
• 1245.23.10148 Boehringer Ingelheim Investigational Site — Lexington, Kentucky, United States
• 1245.23.10034 Boehringer Ingelheim Investigational Site — Rochester, New York, United States
• 1245.23.10123 Boehringer Ingelheim Investigational Site — Smithtown, New York, United States
• 1245.23.10120 Boehringer Ingelheim Investigational Site — Columbus, Ohio, United States
• 1245.23.10031 Boehringer Ingelheim Investigational Site — Oklahoma City, Oklahoma, United States
• 1245.23.10158 Boehringer Ingelheim Investigational Site — Mt. Pleasant, South Carolina, United States
• 1245.23.10015 Boehringer Ingelheim Investigational Site — Simpsonville, South Carolina, United States
• 1245.23.10156 Boehringer Ingelheim Investigational Site — Houston, Texas, United States
• 1245.23.10153 Boehringer Ingelheim Investigational Site — Hurst, Texas, United States
• 1245.23.10143 Boehringer Ingelheim Investigational Site — Killeen, Texas, United States
• 1245.23.10106 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
• 1245.23.10145 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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