Evaluating the Effects of a Study Medication on Exercise Function in Type 2 Diabetes

Inclusion criteria

• Sedentary adults not participating in a regular exercise program (≤ one bout of scheduled exercise per week)
• Subjects must have Type 2 Diabetes
• Subjects must be otherwise healthy
• Ages of 30-60 years
• BMI of 25-39 and stable weight for 3 months prior to the start of the study
• Diabetes controlled by diet +/- insulin secretagogues (sulfonylureas or glinides), metformin, or glucose absorption blockers (acarbose).
• Total glycosylated hemoglobin levels (HbA1C) ≤9% (fair control) on current therapy.

Exclusion criteria

• Any comorbid condition which could limit exercise performance including Chronic Obstructive Pulmonary Disease (COPD) or asthma
• Concurrent enrollment in an interventional study.
• Any tobacco use either current or within the last year
• Clinically evident distal symmetrical neuropathy, determined by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, light touch, ankle jerks), will be excluded.
• Autonomic dysfunction (>20 mm fall in upright BP without a change in heart rate) will be excluded.
• Evidence of ischemic heart disease by history or abnormal resting or exercise electrocardiogram (EKG) (> 1 mm ST segment depression) on screening exercise test.
• Angina or any other cardiovascular, pulmonary or musculoskeletal symptoms
• Presence of systolic blood pressure >190 at rest or >250 with exercise or diastolic pressure >95 at rest or >105 with exercise
• Proteinuria (urine protein >200 mg/dl) or a creatinine > 2 mg/dl, suggestive of severe renal disease
• Proliferative retinopathy
• Insulin, incretin, or glitazone treatment
• Niacin treatment
• History of peptic ulcers
• A history of hereditary angioedema
• C1 esterase deficiency
• Women who are pregnant or breastfeeding
• Use of fibrate drugs