A Single-Dose Crossover Study of MK0893 in Patients With Type 2 Diabetes (0893-019 AM4)(COMPLETED)

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the effect of combined treatment with MK0893 plus propranolol versus placebo plus propranolol on hypoglycemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Propranolol

Criteria

Inclusion Criteria:

• Participant has Type 2 Diabetes (T2DM)

• Participant is either: Not on an oral antihyperglycemic medication for at least 6 weeks; on a single oral antihyperglycemic medication that is not a peroxisome proliferator-activated gamma (PPAR-gamma) agonist (e.g. Avandia); OR on a combination of no more than two antihyperglycemic medications that are not PPAR-gamma) agonists

• Participant has not received insulin for at least 6 months

• Participant has not been treated with a PPAR-gamma agonist for at least 12 weeks

• Participant has been a nonsmoker for at least 6 months

• Female participants who are non-pregnant and highly unlikely to conceive due to surgical sterilization, post-menopausal status, not heterosexually active, or willing to use 2 birth control methods

Exclusion Criteria:

• Participant has a history of stroke, seizures, or neurological disorders

• Participant cannot tolerate insulin or propranolol

• Participant has a history of asthma, emphysema or chronic bronchitis

• Participant is on a weight loss program that is not in the maintenance phase or has been treated with a weight loss medication within 8 weeks of screening

• Participant is on or may require treatment with drugs that affect the immune system or with corticosteroids

• Participant has a history of heart failure or coronary artery disease

• Participant has a history of uncontrolled high blood pressure

• Participant is Human Immunodeficiency (HIV), hepatitis B or hepatitis C positive

• Participant has a history of Type 1 diabetes

• Participant has a history of hypoglycemia unawareness documented by a blood glucose concentration < 55 mg/dL (3.1 mol/L) without symptoms of hypoglycemia.