A Study of MK-0893 on Glucagon-Induced Glycemic Excursion in Healthy Male Participants Following Intravenous Administration of Glucagon, Sandostatine® and Insulin (MK-0893-002)

Summary

This is a study to assess the pharmacokinetics, safety, and tolerability of sequential single oral doses of MK-8093 10 mg, 40 mg, 200 mg, or placebo to MK-8093 (Part 1) depending on treatment assignment in young healthy male participants. In Part 2 of this study, sequential single oral doses of MK-8093 200 mg, 1000 mg or placebo to MK-8093 depending on treatment assignment will be evaluated. The primary hypothesis of the study is that at least one dose of MK-0893 will produce greater reduction of glucagon-induced glycemia as compared to placebo following the infusion of glucagon, Sandostatine®, and basal insulin.

Conditions

• Type 2 Diabetes Mellitus

Interventions

DRUG

MK-0893 10 mg

MK-0893 10 mg administered orally in 240 mL of water

DRUG

MK-0893 40 mg

MK-0893 40 mg administered orally in 240 mL of water

DRUG

MK-0893 200 mg

MK-0893 200 mg administered orally in 240 mL of water

DRUG

MK-0893 1000 mg

MK-0893 1000 mg administered orally in 240 mL of water

DRUG

Placebo

Placebo administered orally in 240 mL of water

BIOLOGICAL

Sandostatine®

Sandostatine® is a somatostatin analogue. At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous Sandostatine® will be administered at 30 ng/kg/min.

BIOLOGICAL

Insulin

At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous insulin will be administered at 0.10 milli-international unit (mIU)/kg/min.

BIOLOGICAL

Glucagon

At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous glucagon will be administered at 3 ng/kg/min.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  lead INDUSTRY

Principal Investigators

• Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2005-07-31

Primary Completion

2005-12-31

Completion

2005-12-31