Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Impact of LY2189265 Versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3)
Brief Summary: The purpose of this study is to determine if LY2189265 is safe and effective in reducing glycosylated hemoglobin (HbA1c) as compared to metformin in participants with Type 2 Diabetes.


Options:
A: Inclusion Criteria:

* Coronary heart disease
* Type 2 diabetes

Exclusion Criteria:

* Severe organ dysfunction, psychopathy, infection, neutropenia
* Congenital heart disease, rheumatic heart disease, severe arrhythmia, myocardiopathy
B: Inclusion criteria:

* patients completing one of double blind phase II trials 1245.9 or 1245.10
* informed consent

Exclusion criteria:

* patients meeting withdrawal criteria of preceding trial
* significant hepatic impairment
* significant renal impairment with creatinine clearance \< 50 ml/min
* contraindication to Metformin for all patients treated with Metformin
* premenopausal women that are nursing or pregnant or not practicing acceptable methods of birth control
* drug or alcohol abuse
C: Inclusion Criteria:

* Have type 2 diabetes for greater than or equal to 3 months and less than or equal to 5 years based on the disease diagnostic criteria (refer to the World Health Organization's \[WHO\] Classification of Diabetes).
* Are treatment-naïve, not optimally controlled with diet and exercise alone, or are taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding thiazolidinediones). For those on 1 OAM, the dose must be less than or equal to 50% the maximum authorized per local label.
* Are able and willing to tolerate a minimum dose of 1500 milligrams per day (mg/day) or up to 2000 mg/day of metformin.
* Have glycosylated hemoglobin (HbA1c) greater than or equal to 6.5% to less than or equal to 9.5%.
* Females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must: a) test negative for pregnancy at screening based on a serum pregnancy test, and b) agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or c) not be breastfeeding.
* Have a stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening.
* Have a body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m\^2), inclusive.
* Are well-motivated, capable, and willing to: a) perform self-monitored blood glucose (SMBG) testing; b) learn how to self-inject treatment (LY2189265 or placebo) and c) maintain a study diary.

Exclusion Criteria:

* Have type 1 diabetes mellitus.
* Are being or have been treated with any of the following medications: a) chronically treated with insulin for the treatment of diabetes in the past; however, a short-term use of insulin more than 3 months prior to screening is allowable, b) glucagon-like peptide 1 (GLP-1) analogs within 3 months prior to this screening, c) drugs to cause weight loss within 3 months prior to screening, d) thiazolidinediones (TZDs) within 3 months prior to screening, e) chronically treated (greater than or equal to 14 days) with an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening, or f) illegal drugs.
* Have had 1 or more cases of uncontrolled diabetes that required hospitalization in the 6 months prior to screening.
* Have stomach problems, have chronically taken medication to increase movement in the digestive tract or slow down the emptying of the digestive tract, or have had gastric bypass (bariatric) surgery.
* Have had problems with the heart or brain in the past 2 months prior to screening, such as a heart attack, chest pain, heart failure, heart bypass operation, angioplasty or stent insertion, a heart rhythm problem, or a stroke.
* Have a serum creatinine result which shows a greater than or equal to 1.5 milligrams per deciliter (mg/dL) for men or greater than or equal to 1.4 mg/dL for women.
* Have a problem with the liver or pancreas.
* Have a creatinine clearance result which shows less than 60 milliliters per minute (mL/min), evidence of a significant active, uncontrolled endocrine (hormone), or active autoimmune abnormality.
* Have a serum calcitonin test which shows greater than or equal to 20 picograms per milliliter (pcg/mL) at the time of screening.
* Have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B.
* Have cancer (except for skin cancer) or have been in remission from cancer for less than 5 years.
* Have had an organ transplant except for corneal transplant.
* Have received treatment within the last 30 days with a drug which has not been regulatory approved.
* Have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed within 30 days prior to screening.
* Have any condition that is a contraindication to or would interfere with medications provided for this study to treat diabetes.
* Have a blood disorder that would interfere with the drawing of blood glucose measurements or lab samples.
* Have previously participated or signed an informed consent document for this same type of study and study drug.
D: Inclusion Criteria:

* Men and women ≥18 years old
* T2D (according to World Health Organization (WHO) criteria) of less than 4 years duration
* BMI 18.5-45 kg/m2
* Drug naïve or oral monotherapy with glucose-lowering drug.
* Accepting NDR participation and other register data collection.

Exclusion Criteria:

* Known or suspected other form of diabetes than type 2
* Ongoing or more than \>4 weeks in total of any previous treatment with: insulin, GLP-1 receptor agonists, SGLT2 inhibitors or combination of any diabetes medications
* Medical need to start or intensify any specific GLD treatment, e.g. insulin due to marked hyperglycemia
* HbA1c \>70 mmol/mol for patients on monotherapy, \>80 in drug naïve
* Contraindication to either metformin or dapagliflozin, or any unacceptable risk with either treatment as assessed by the investigator
* History or signs of established cardiovascular disease: diagnosis of myocardial infarction, angina pectoris, heart failure, stroke, lower extremity arterial disease, any limb amputation (except due to trauma or malignancy)
* Any serious illness or other condition with short life expectancy (\<4 yr)
* Renal impairment (eGFR \<60 ml/min/1,73m2)
* Any condition, as judged by the investigator, that suggests that the patient will be non-compliant or otherwise unsuitable to study medication or study participation
* Pregnancy or breastfeeding, women of childbearing potential (WOCBP; including perimenopausal women who have had a menstrual period within 1 year) without adequate anticonception during any part of the study period
* Involvement in the planning and/or conduct of the study
* Ongoing participation in another clinical trial.

Answer: C