Please select the eligibility criteria that correspond to the clinical trial below.
Title: TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Sitagliptin in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control
Brief Summary: This is a clinical trial designed to assess the cardiovascular outcome of long-term treatment with sitagliptin used as part of usual care compared to usual care without sitagliptin in participants with type 2 diabetes mellitus (T2DM) having a history of cardiovascular (CV) disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%.

Primary hypothesis A is that sitagliptin, when used as part of usual care, is non-inferior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint of Major Adverse Cardiovascular Event (MACE) plus. If hypothesis A is satisfied: hypothesis B is that sitagliptin, when used as part of usual care, is superior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint.


Options:
A: Inclusion Criteria:

* Type 2 Diabetes
* Treatment with a stable sulphonylurea monotherapy dose that is at least half the maximal recommended dose for a minimum of 8 weeks prior to study
* Inadequate glycaemic control, defined as A1C ≥ 7.0 % and ≤ 10%

Exclusion Criteria:

* Type 1 Diabetes
* Hepatic (liver) impairment
* Renal (kidney) failure or dysfunction
B: Inclusion Criteria:

* Type 2 Diabetes Mellitus of mor than 1year
* GFR less than 30 ml/min/1.73m2 or dialysis
* Age greater than 18years
* Entry blood glucose (fasting or random) greater than 180mg%

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* New onset hyperglycemia
* Pregnant
* Solid organ transplant within 1 year
* Steroids prednisone greater than 7.5mg/day or equivalent
* Hospital LOS predicted less than 2 days
* Severe liver disease
* Known hypopituitarism or adrenal insufficiency
* Patients in the ICU
* Patients with hypoglycemic unawareness
* Outpatient insulin dose less than 0.6 units/kg
C: Inclusion Criteria:

* Patients with T2DM with inadequate glycemic control (based upon fasting glucose measurements \>=130 mg/dL and \<=250 mg/dL) on metformin monotherapy or on metformin in dual combination with other glucose lowering agents (sulphonylurea \[SU\] or a meglitinide or a dipeptidyl peptidase-4 \[DPP-4\] inhibitor) are eligible for enrollment in the study.

Exclusion Criteria:

* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
* history of a severe hypoglycemic episode within 6 months before screening
* Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or fasting self-monitored blood glucose (SMBG) measurements \>=250 mg/dL (13.88 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling
* History of or current illness considered to be clinically significant by the investigator
D: Inclusion Criteria:

* Has T2DM
* Has HbA1c between 6.5% (48 mmol/mol) and 8.0% (64 mmol/mol) on stable dose(s) of antihyperglycemic agent(s), including insulin
* Has pre-existing cardiovascular disease

Exclusion Criteria:

* Has a history of type 1 diabetes mellitus or ketoacidosis.
* Is not able to take sitagliptin

Answer: D