Clinical trial: Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes (NCT01012037)

Eligibility criteria:
Inclusion criteria

          1. Diagnosis of type 2 diabetes mellitus.

          2. Current treatment with metformin alone (>/= 1500 mg or maximally tolerated dose) or
             metformin plus 1 other antidiabetic drug. Metformin must be administered in twice
             daily dosing regimen. Patients taking metformin three times daily can be included if
             posology is switched to twice daily and total daily dose is maintained.

          3. Glycosylated haemoglobin (HbA1c) is between 7.0% - 10.0%.

          4. Body Mass Index (BMI) </=45 kg/m2.

        Exclusion criteria

          1. Treatment with extended release metformin.

          2. Uncontrolled hyperglycaemia (fasting plasma glucose > 240 mg/dL or 13.3 mmol/L).

          3. Myocardial infarction (MI), stroke or transient ischaemic attack (TIA) within 6 months
             prior to informed consent.

          4. Impaired hepatic or renal function, or gastric bypass surgery.

          5. Treatment with glitazones, glucagon like peptide-1 (GLP-1) analogues/mimetics,
             antiobesity agents, or insulin within 3 months of informed consent.

          6. Current treatment with systemic steroids or change in dosage of thyroid hormones.

          7. Alcohol or drug abuse within 3 months of informed consent.

          8. Participation in another trial with investigational drug within 2 months prior to
             informed consent.

          9. Pre-menopausal women who are nursing, pregnant or not practicing an acceptable method
             of birth control.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Entailment