Study of Raisins Versus Alternative Snacks in Patients With Type 2 Diabetes Mellitus

Inclusion Criteria

• Are generally healthy men and women older than 18 years of age
• Are willing and able to undergo an informed consent process
• Have medical history of Type 2 Diabetes Mellitus
• Have hemoglobin A1c 67.5 - 10%
• Have body mass index (BMI) 25.0 to 39.9 kg/m2
• Have blood pressure > 100 mmHg systolic or > 70 mmHg diastolic
• Are willing and able to perform self-glucose monitoring throughout the study
• Are willing to fast before study visits
• Are willing and able to bring in their morning anti-diabetes mellitus drugs to study visits
• Women must be of non-childbearing potential defined as postmenopausal for at least 2 years or surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
• If not menopausal or surgically sterile, then women of child-bearing potential must be willing to use:
• oral contraceptives and another acceptable form of birth control, or
• double barrier birth control methods such as condom or occlusive cap (e.g. diaphragm or cervical/vault caps) plus spermicidal agent (e.g. foam, gel, film, cream, suppository).
• Are willing to notify the research staff of any change in their medical health & concomitant medications/supplements during the course of the clinical trial

Exclusion Criteria

• Intolerance, dislike, or unwillingness to consume raisins or any of the comparator snacks and affiliated ingredients
• History of greater than one drug allergy
• History of greater than one "food allergy"
• Change in anti-diabetes mellitus medication within 3 months prior to screening visit
• Change in blood pressure and/or lipid-altering medications within 1 month of screening visit
• Plans to change current anti-diabetes mellitus, blood pressure, or lipid-altering medications during course of the study
• Unwilling to maintain current anti-diabetes mellitus, blood pressure, or lipid-altering medications and their doses during the course of the study
• History of clinically significant diabetes mellitus complications, that in the opinion of the investigator, may interfere with the successful completion of the trial
• History of clinically significant diabetes mellitus kidney disease (e.g. clinically significant proteinuria)
• History of severe high or low blood sugars within the past year, as per Investigator discretion
• History of severe high or low blood sugars requiring hospitalization at any time in the past
• Subjects are excluded if within the past 6 months, they have history of myocardial infarction, acute coronary syndrome, stroke, or any cardiac / vascular surgical procedure (e.g. atherosclerotic coronary heart disease by-pass, carotid surgery, peripheral vascular by-pass, stent placement, pacemaker placement, etc.), unstable angina, or alterations in treatment of stable angina
• Subjects are excluded if at any time in the past, they have history of clinically significant ventricular or atrial dysrhythmias
• Subjects are excluded if at any time in the past, they have history of New York Heart Association (NYHA) functional heart failure of Class III or greater, defined as: CLASS III: Marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes fatigue, palpitations or dyspnea, CLASS IV: Unable to carry out any physical activity without discomfort, symptoms of cardiac insufficiency at rest, if any physical activity is undertaken, discomfort is increased
• Subjects are excluded if at any time in the past, they have history of or known increases in QTc
• History of seizures in the past year
• Is pregnant, breastfeeding or plans to become pregnant during the course of the clinical trial
• Major surgical procedure within 30 days prior to visit #1 (i.e. day of signing of the informed consent document), or current plans to have a major surgical procedure during study participation or 30 days following completion of all study related procedures
• History of gastrointestinal malabsorption (e.g. uncontrolled crohn's disease, et