Type 2 Diabetes Mellitus MedDRA version: 13.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Boehringer Ingelheim Ellas AE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus prior to informed consent 2. Male and female patients on diet and exercise regimen who are pre-treated with pioglitazone alone or in combination with metformin (see below for minimum doses). The treatment regimen should be unchanged for 12 weeks prior to randomisation. Minimum dose for pioglitazone: = 30 mg/day or maximum tolerated dose or maximum dose according to the local label Minimum dose for metformin: = 1500 mg/day or maximum tolerated dose or maximum dose according to the local label 3. HbA1c of = 7.0% and /= 18 5. BMI =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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) 2. Any other antidiabetic medication within 12 weeks prior to randomisation, except those defined as the permitted background therapy via inclusion criteria no. 2 3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischaemic attack (TIA) within 3 months prior to informed consent 4. 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 or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3) 5. Impaired renal function, defined as eGFR (estimated Glomerular Filtration Rate) < 30 ml/min (severe renal impairment, MDRD [Modification of Diet in Renal Disease] formula) as determined during screening or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3) 6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption 7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years 8. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g. malaria, babesiosis, haemolytic anaemia) 9. Contraindications to pioglitazone according to the local label 10. Contraindication to pioglitazone in combination with metformin (relevant only for those patients who enter the study with this background therapy) according to the local label 11. 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 12. 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 T2D 13. 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 trial 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 to local authorities), double barrier method and vasectomised partner 14. 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 15. Participation in another trial with an investigational drug within 30 days prior to informed consent 16. Any other clinical condition that would jeopardise patient safety while participating in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 (10 and 25 mg/once daily) compared to placebo given for 24 weeks as add-on therapy to pioglitazone alone or in combination with metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. The study is designed to show superiority over placebo. ;Secondary Objective: The key secondary endpoint is: • change from baseline after 24 weeks in the fasting plasma glucose (FPG) Other exploratory efficacy endpoints are the following: • HbA1c: Occurrence of treat to target efficacy response, that is an HbA1c of 0.5% or HbA1c 3 mmHg - body weight reduction of > 2% ;Primary end point(s): The primary endpoint in this trial is the change from baseline in HbA1c after 24 weeks of treatment. Throughout the trial protocol, the term "baseline" refers to the last observation prior to the administration of any randomised study medication. | — |
Countries
Greece
Outcome results
None listed