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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

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

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

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

Clinical Details

Official title: A Double-Blind, Randomized, Placebo-Controlled, Single-Dose Crossover Study to Assess the Safety and Tolerability of MK0893 Coadministered With Propranolol Hydrochloride in Patients With Type 2 Diabetes

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

Primary outcome: Recovery Time (Rt[65] From Insulin-induced Hypoglycemia

Secondary outcome:

Maximum Plasma Concentration (Cmax) and Concentration Average Over 8-12 Hours (C[Ave] 8-12 hr) Post Single Dose MK0893

Plasma Concentration at 32 Hours (C[32hr]) Post Single Dose MK0893

Number of Participants With An Adverse Event (AE)

Number of Participants Who Discontinued Study Treatment Due To AEs

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: May 2009
Last updated: June 8, 2015

Page last updated: August 23, 2015

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