Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled Comparison of the Effects of Two Doses of LY2189265 or Exenatide on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Pioglitazone (AWARD-1: Assessment of Weekly Administration of LY2189265 in Diabetes-1)
Brief Summary: The purpose of this study is to determine if LY2189265 is effective and safe in reducing hemoglobin A1c (HbA1c), as compared to placebo (no medicine), or exenatide in participants with Type 2 Diabetes. The participants must also be taking metformin and pioglitazone.


Options:
A: 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.
B: Inclusion Criteria:

* Type 2 Diabetes (T2D) not well controlled on 1, 2, or 3 oral antidiabetic medications

  1. Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication
  2. HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications
* Able to tolerate minimum dose of 1500 milligrams (mg) metformin a day and 30 mg pioglitazone per day.
* Willing to inject subcutaneous (SC) medication up to 2 times per day
* Stable weight for 3 months prior to screening
* Body mass index (BMI) between 23 and 45 kilograms per meter squared (kg/m\^2)
* Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.

Exclusion Criteria:

* Type 1 Diabetes
* HbA1c equal to or less than 6.5 before randomization or at randomization
* Chronic insulin use
* Taking drugs to promote weight loss by prescription or over the counter
* Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled
* History of fluid retention or edema
* History of Heart Failure New York Heart Classification II, III, or IV or acute myocardial infarction or stroke within 2 months of screening
* Gastrointestinal (GI; stomach) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility
* Hepatitis or liver disease or alanine transaminase (ALT) greater than 2.5 times the upper limit of normal
* Acute or chronic pancreatitis of any form
* Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatine clearance of less than 60 milliliters per minute (mL/min)
* History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer
* A serum calcitonin greater than or equal to 20 picograms per milliliter (pg/mL) at screening
* Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
* History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years
* Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing
* Organ transplant except cornea
* Have enrolled in another clinical trial within the last 30 days
* Have previously signed an informed consent or participated in a LY2189265 (dulaglutide) study
* Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening
C: Inclusion criteria:

* Newly diagnosed patients (\< 3years) with type 2 diabetes.
* Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.
* No previous treatment with oral or parenteral glucose-lowering therapy.

Exclusion criteria:

* History of lactic acidosis.
* Anemia (\<11g for males, \<10 g for females).
* Unstable or severe NY Heart Association-class 3 or 4.
* Any NY Heart Association congestive heart failure.
* Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.
D: Inclusion criteria

1. Age between 45 and 65 years.
2. All patients are going to give their informed consent to participate in the study.
3. Patients who are not receiving antihypertensive or diabetes treatment (newly diagnosed diabetics)
4. BP between 130 to 140 mmHg for systolic BP (prehypertensives)
5. Type II diabetes (HbA1c 7.0-8.0)

Exclusion criteria

1. Known oversensitiveness
2. chronic renal disease (GFR\<60 ml/min) or ESRD
3. heart or respiratory failure, recent MI, shock
4. pregnancy or lactation.

Answer: B