patients with IGT or type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 MedDRA version: 9.1 Level: LLT Classification code 10018429
Conditions
Sponsors
BOEHRINGER ING.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1a. Male and female patients diagnosed with IGT according to the current ADA guidelines as a two-hour glucose levels of 140 to 199 mg/dl (7.8 mmol/l to 11.1 mmol/l) on the 75-g oral glucose tolerance test, with an OGTT performed at the time of the screening visit (Visit 1), or 1b. Male and female patients diagnosed with type 2 diabetes mellitus prior to informed consent, on diet and exercise regimen who are drug-na?ve, defined as absence of any oral antidiabetic therapy or insulin for 12 weeks prior to the planned Day 1 of the trial, or, 1c. Male and female patients diagnosed with type 2 diabetes mellitus prior to informed consent, who are pre-treated with metformin background therapy, on a stable dose of metformin of at least 1500 mg per day, unchanged for at least 12 weeks prior to the planned Day 1 in the trial. 2. HbA1c at Visit 1 (screening): a. For patients diagnosed of IGT: HbA1c =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Myocardial infarction, stroke or TIA within 6 months prior to informed consent. 2. Any other antidiabetic drug within 12 weeks prior to starting the open-label active treatment (Visit 4) except those defined as background via inclusion criterion 1c. 3. 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. 4. Impaired renal function, defined as eGFR < 60 ml/min (moderate and severe renal impairment) as determined during screening and/or run-in phase. 5. Medical history of insufficient bladder emptying (i.e. neurogenic bladder disorders). 6. Patients with an Hb < 11.5 mg/dl (for males) and Hb < 10.5 mg/dl (for females) at Visit 1. 7. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption within the last 5 years. 8. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years. 9. For patients on metformin background therapy, the investigator must check for potential exclusion criteria according to local metformin label. 10. 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. 11. 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 T2DM. However, the use of inhaled steroids (e.g., for asthma, COPD) is not an exclusion as these do not cause systemic steroid action. 12. Alcohol or drug abuse (according to investigators judgment) 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. 13. Participation in another trial with an investigational drug within 30 days prior to informed consent. 14. 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 (IUD/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the acute and chronic effects of BI 10773 on fasting and postprandial glucose homeostasis in patients with IGT and type 2 diabetes mellitus. This includes the analysis of gut and pancreatic hormones, endogenous glucose production, beta cell function and urinary glucose excretion;Secondary Objective: Secondary efficacy endpoints: • Change in rate of endogenous glucose production, urinary glucose excretion, gut and pancreatic hormonal control of endogenous glucose, beta cell function, insulin sensitivity, lipolysis and energy expenditure individual`s rate after one dose, and after 28 days of treatment and change from baseline in HbA1c after 28 days of treatment. Endpoint(s) of safety: Adverse events, hypoglycaemic events, protocol-specified significant adverse events, cardiovascular events and changes from baseline in clinical laboratory values;Primary end point(s): The primary endpoint in this study is the change in glucose metabolism (fasting and postprandial glucose) in patients with IGT, and patients with T2DM on diet or metformin, from baseline to the first administration of the study medication, and to 28 days of treatment. | — |
Countries
Austria, Germany, Italy
Outcome results
None listed