Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Glimepiride
Brief Summary: The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes. Participants must also be taking metformin and glimepiride.


Options:
A: Inclusion Criteria:

54-Week Base Study:

* Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type of diabetes)

  50-Week Extension Study:
* Patients who complete the 54-week base study are eligible to enter the 50-week extension study

Exclusion Criteria:

* Patients who do not have Type 2 Diabetes Mellitus (a specific type of diabetes)
B: Inclusion Criteria:

* Female, \>55 to \<80 years
* \>5 years menopausal
* Type 2 Diabetes Mellitus (T2DM) diagnosis according to American Diabetes Association (ADA), American Association of Clinical Endocrinologists (AACE), Canadian Diabetes Association (CDA), World Health Organization/International Diabetes Federation (WHO/IDF)
* Drug-naïve (HbA1c \< or = 9.0%); OR Prior monotherapy, submaximal doses of metformin (\< or = 1000mg Metformin), sulfonylureas (\< or = 5mg Glyburide, \< or = 10mg Glipizide or \< or = 8mg glimepiride) or full dose Januvia (100mg) (HbA1c \< or = 8.5%); OR Prior monotherapy, \> submaximal doses of metformin (\>1000mg) or sulfonylureas (\>5mg Glyburide, \>10mg Glipizide or \>8mg glimepiride) (HbA1c \< or = 7.0%)
* Weighs \<300 lbs (136.4 kg)
* Two or more vertebra (L1-L4) suitable for BMD measurement by dual x-ray absorptiometry (DXA)
* Absolute BMD value consistent with T-score \>-2.5 at femoral neck, lumbar spine and total hip

Exclusion Criteria:

* Type 1 Diabetes Mellitus (T1DM) or history of diabetic ketoacidosis (DKA)
* Renal or hepatic disease (clinically significant)
* Hepatocellular reaction, severe edema, or medically serious fluid event associated with thiazolidinedione (TZD)
* Recent (\<6mos) history or clinical intervention for angina or myocardial infarction or is taking nitrates
* Any stage of heart failure, i.e. New York Heart Association (NYHA) class I-IV
* Systolic BP \>160mmHg or diastolic BP \>90mmHg while on antihypertensive
* Hypersensitivity to TZDs, biguanides
* Prior treatment with two or more oral anti-diabetic (OAD) agents
* Bilateral hip replacements
* Concurrent diseases affecting bone metabolism
* Active malabsorption syndrome
* Serum calcium outside the central lab reference range
* Thyroid replacement therapy, serum thyroid stimulating hormone (TSH) must be within range
* Vitamin D deficiency
* Previous treatment with: strontium, intravenous (IV) bisphosphonate, fluoride, hormones, calcineurin inhibitors or methotrexate
* Chronic systemic corticosteroid \[e.g. glucocorticoid, mineralocorticoid\] treatment of no more than two intra-articular injections within the past year or use of oral parenteral, or long-term, high-dose inhaled corticosteroids
C: Inclusion Criteria:

* Not previously treated with oral antidiabetic agents as defined by the protocol
* Blood glucose criteria must be met
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular complications
* Laboratory value abnormalities as defined by the protocol
* Known sensitivity to pioglitazone
* Other protocol-defined exclusion criteria may apply
D: Inclusion Criteria:

* Type 2 Diabetes not well controlled on 1, 2, or 3 oral antidiabetic medications (at least one of them must be metformin and/or a sulfonylurea)

  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
* Accept treatment with metformin and glimepiride throughout the study, as per protocol
* Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for Insulin Glargine.
* Stable weight for 3 months prior to screening
* Body mass index (BMI) between 23 and 45 kilograms per square meter (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 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 Heart Failure New York Heart Classification III or IV, or acute myocardial infarction, or stroke within 2 months of screening
* Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility
* Hepatitis or liver disease or ALT (alanine transaminase) greater than 3.0 of upper normal limit
* 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 creatinine 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 (pcg/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 study
* Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening

Answer: D