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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: MK0893; Drug: MK0893-matched Placebo; Drug: Propranolol Hydrochloride (HCL)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00902161

0893-019

2009_592

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 2 patient groups, including a placebo group

Propanolol + Placebo > Propanolol + MK0893

Experimental group

Description:

Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893-matched placebo was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893 on Day 21 (Visit 8).

Treatment:

Drug: MK0893

Drug: MK0893-matched Placebo

Drug: Propranolol Hydrochloride (HCL)

Propanolol + MK0893 > Propanolol + Placebo

Placebo Comparator group

Description:

Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893 was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893-matched placebo on Day 21 (Visit 8).

Treatment:

Drug: MK0893

Drug: MK0893-matched Placebo

Drug: Propranolol Hydrochloride (HCL)