Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes
Brief Summary: This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.


Options:
A: Inclusion Criteria

* Type 2 diabetes mellitus
* Glycosylated hemoglobin above the upper limit of normal (ie, the local equivalent of 6.5% for)
* Established history of macrovascular disease, defined as 1 or more of:

  * Myocardial infarction at least 6 months before entry into the study.
  * Stroke at least 6 months before entry into the study
  * Percutaneous coronary intervention or coronary artery bypass graft at least 6 months before entry into the study.
  * Acute coronary syndrome at least 3 months before entry into the study.
  * Objective evidence of coronary artery disease.
  * Peripheral arterial obstructive disease

Exclusion Criteria

* Signs of type 1 diabetes.
* Patients prescribed insulin as sole therapy for glycemic control of diabetes for 2 weeks or more at any time in the previous 3 months.
* Myocardial infarction, stroke, coronary artery bypass graft, or percutaneous cardiac intervention in the 6 months prior to enrolment.
* Acute coronary syndrome in the 3 months prior to enrolment.
* Heart failure at entry defined as patient having a New York Heart Association functional score of II or above.
* Had an appointment for a coronary angiogram or endovascular or surgical intervention.
* Leg ulcers, gangrene, or ischemic rest pain.
* Had an appointment for an angiogram or endovascular or surgical intervention for leg ischemia.
* Had undergone a major operation (defined as a surgical procedure lasting for more than 30 minutes) at any time in the previous 4 weeks.
* Significantly impaired hepatic function, defined as alanine aminotransferase greater than 2.5 times the upper limit of normal.
* Familial polyposis coli.
* Required dialysis.
* History of alcohol or drug abuse.
* Any other intercurrent disease believed to be likely to have a significant impact on the patient's life expectancy during the course of the study (eg, cancer).
* Patient was undergoing follow-up as part of another clinical trial or less than 3 months had elapsed since the last dose of an investigational drug or procedure.
* Hypersensitivity to pioglitazone or other TZD.
* Current use of pioglitazone or other TZD.
* Patient was known to be infected with human immunodeficiency virus or was known to have viral hepatitis.
* Women who were any of the following: pregnant, breast feeding, wished to become pregnant during the course of the study or of childbearing potential and not planning to use a reliable method of contraception throughout the study.
B: Inclusion Criteria:

* Type 2 diabetes
* TTreatment with diet/exercise or with not more than half maximal dose of oral anti-diabetic drugs alone for at least 2 months
* Diet/exercise treated subjects with HbA1c between 7.0% and 11%, inclusive
* OAD (oral anti-diabetic drug) treated subjects with HbA1c between 7.0% and 10%, inclusive
* Body Mass Index (BMI) less than or equal to 45 kg/m\^2

Exclusion Criteria:

* Treatment with insulin for the last 3 months, except short-term treatment for intercurrent illness
* Treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound)
* Any serious medical condition
C: Inclusion Criteria:

* Type 2 diabetes
* Stable treatment with Oral Anti-Diabetic Drugs (metformin, sulphonylurea or a combination of both) for at least 3 months at the discretion of the Investigator
* HbA1C equal to or greater than 7.0% and equal to or lower than 11.0%
* Body Mass Index (BMI) equal to or lower than 45.0 kg/m2

Exclusion Criteria:

* Previous treatment with insulin
* Treatment with any anti-diabetic drug other than metformin and sulphonylurea
* Any previous exposure to exenatide or liraglutide
* Impaired liver or/and renal function
* History of any significant cardiac events
* Known retinopathy or maculopathy requiring acute treatment
* Recurrent major hypoglycaemia or hypoglycaemic unawareness
D: Inclusion Criteria:

* Type 2 diabetes
* Treatment with oral anti-diabetic drugs for at least 3 months
* HbA1c: 7.5-10.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy.
* Body Mass Index (BMI) less than or equal to 45 kg/m2

Exclusion Criteria:

* Treatment with insulin within the last 3 months
* Treatment with any drug that could interfere with the glucose level
* Any serious medical condition
* Females who are pregnant, have intention of becoming pregnant or are breastfeeding

Answer: C