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)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled, Single-Dose, 3-Period, 4 Treatment Incomplete Crossover Study to Assess the Effects of Single Oral Doses of L-001241689 on Glucagon-Induced Glycemic Excursion in Healthy Male Subjects Following Intravenous Administration of Glucagon, Sandostatine® and Insulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012166
• Other study ID #: 0893-002
• Secondary ID: 2005-002198-57
• Status: Completed
• Phase: Phase 1
• First received: December 3, 2013
• Last updated: August 18, 2015
• Start date: July 2005
• Est. completion date: December 2005

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Good health

• Body Mass Index of between 18 and 28 kg/m^2, or up to 30 kg/m^2 with approval of sponsor

• Non-smoker for at least 6 months

• Willing to avoid strenuous physical activity

• Willing to avoid alcohol, caffeine, and grapefruit juice consumption

Exclusion Criteria:

• History of renal, neurologic, gastrointestinal or respiratory disease or any gastrointestinal surgery

• History of multiple and/or severe allergies to a prescription, nonprescription or investigational drug or food

• History of any cardiovascular/cardiac disease

• History of any hepatic disease and primary biliary cirrhosis

• History of hypoglycemia or glucose intolerance, type 1 diabetes, or type 2 diabetes

• Requires or anticipates use of prescription or nonprescription medications, including herbal remedies

• A user of any illicit drugs or a history of drug or alcohol abuse

• Surgery, donated a unit of blood, or participated in another clinical study within 4 weeks prior to study participation

• History of hypersensitivity to insulin, glucagon, or Sandostatine®.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• MK-0893 10 mg
MK-0893 10 mg administered orally in 240 mL of water
• MK-0893 40 mg
MK-0893 40 mg administered orally in 240 mL of water
• MK-0893 200 mg
MK-0893 200 mg administered orally in 240 mL of water
• MK-0893 1000 mg
MK-0893 1000 mg administered orally in 240 mL of water
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 1		Up to 76 hours postdose	No
Primary	Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 2		Up to 124 hours postdose	No
Secondary	Number of Participants With An Adverse Event (AE)		Up to 12 weeks	Yes
Secondary	Number of Participants Who Discontinued Study Treatment Due To AEs		Up to 21 days of each treatment period	Yes