Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 12:46 AM
NCT ID:
NCT01924767
Eligibility Criteria:
Inclusion criteria:
1. Male and postmenopausal or hysterectomised female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or on a maximum of two oral antidiabetic agents except thiazolidindiones with at least one agent taken at 50% of its maximum dose or less.
2. Glycosylated haemoglobin A1 (HbA1c) £ 8.5 % at screening.
3. Age \>21 and Age \<70 years (male and hysterectomised female patients) Age \>60 and Age \<70 years (postmenopausal female patients)
4. Body Mass Index (BMI) \>18.5 and \<40 kg/m2
5. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Exclusion criteria:
1. Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent (except if 2 agents and at least one of them not taken at more than 50% of its maximum dose)
2. Fasted blood glucose \> 240 mg/dl (\>13.3 mmol/L) on two consecutive days during washout.
3. Glycosylated haemoglobin A1 (HbA1c) \>8.5% at screening
4. Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as:
* Any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot)
* Renal insufficiency (calculated creatinine clearance \< 80 ml/min/1.73m²)
* Cardiac insufficiency NYHA II-IV, myocardial infarction, other known cardiovascular diseases including hypertension \> 160/95mmHg (measured at training visit and each of the timepoints of Day -1), stroke and TIA (Transistoric ischaemic attack)
* Neurological disorders (such as epilepsy) or psychiatric disorders
* Acute or relevant chronic infections (e.g. HIV, repeated urogenital infections)
* Any gastrointestinal, hepatic, respiratory, endocrine or immunological disorder
5. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
6. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms)
7. A history of additional risk factors for TdP (torsade des pointes) (e.g., heart failure, hypokalemia, family history of sudden death before the age of 50)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01924767
Study Brief:
Protocol Section:
NCT01924767