Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin 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 aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.

Key facts

Study ID

NCT01177813

Run by

Boehringer Ingelheim

People needed

986

Starts

2010-07-01

Last updated by the study team

2014-06-16

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-naïve;
• HbA1c >= 7.0% and <= 10.0% at Visit 1 (screening) for randomised treatment; HbA1c > 10.0% at visit 1 (screening) for the open-label BI 10773 arm;
• Age >= 20 (Japan); Age >= 18 (countries other than Japan);
• BMI <= 45 kg/m2 at Visit 1 (screening);
• Signed and dated written informed consent by date of Visit 1

You may not qualify if…

• Uncontrolled hyperglycaemia;
• Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent;
• Indication of liver disease, either ALT, AST, or alkaline phosphatase above 3 x ULN;
• Impaired renal function (eGFR<50 ml/min);
• Bariatric surgery within the past two years or other GI surgeries;
• Medical history of cancer;
• Contraindications to sitagliptin;
• Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell;
• Treatment with any anti-diabetes drug within 12 weeks prior to randomisation;
• Treatment with anti-obesity drugs or any other treatment leading to unstable body weight;
• Current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM;
• Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and not practicing an acceptable method of birth control;
• Alcohol or drug abuse;
• Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial;
• Any other clinical condition that would jeopardize patients safety while participating in this clinical trial

Where it is running

• 1245.20.10108 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 1245.20.10150 Boehringer Ingelheim Investigational Site — Hot Springs, Arkansas, United States
• 1245.20.10154 Boehringer Ingelheim Investigational Site — Chino, California, United States
• 1245.20.10009 Boehringer Ingelheim Investigational Site — Santa Ana, California, United States
• 1245.20.10131 Boehringer Ingelheim Investigational Site — West Hills, California, United States
• 1245.20.10038 Boehringer Ingelheim Investigational Site — Northglenn, Colorado, United States
• 1245.20.10137 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 1245.20.10006 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1245.20.10085 Boehringer Ingelheim Investigational Site — Plantation, Florida, United States
• 1245.20.10078 Boehringer Ingelheim Investigational Site — Tampa, Florida, United States
• 1245.20.10080 Boehringer Ingelheim Investigational Site — Decatur, Georgia, United States
• 1245.20.10128 Boehringer Ingelheim Investigational Site — Avon, Indiana, United States
• 1245.20.10060 Boehringer Ingelheim Investigational Site — Fishers, Indiana, United States
• 1245.20.10065 Boehringer Ingelheim Investigational Site — Indianapolis, Indiana, United States
• 1245.20.10117 Boehringer Ingelheim Investigational Site — Arkansas City, Kansas, United States
• 1245.20.10039 Boehringer Ingelheim Investigational Site — Wichita, Kansas, United States
• 1245.20.10146 Boehringer Ingelheim Investigational Site — Louisville, Kentucky, United States
• 1245.20.10144 Boehringer Ingelheim Investigational Site — Watertown, Massachusetts, United States
• 1245.20.10115 Boehringer Ingelheim Investigational Site — Brick, New Jersey, United States
• 1245.20.10129 Boehringer Ingelheim Investigational Site — Carlisle, Ohio, United States
• 1245.20.10045 Boehringer Ingelheim Investigational Site — Cincinnati, Ohio, United States
• 1245.20.10119 Boehringer Ingelheim Investigational Site — Cincinnati, Ohio, United States
• 1245.20.10130 Boehringer Ingelheim Investigational Site — Gallipolis, Ohio, United States
• 1245.20.10089 Boehringer Ingelheim Investigational Site — Houston, Texas, United States
• 1245.20.10124 Boehringer Ingelheim Investigational Site — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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