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A Single-Dose Crossover Study of MK0893 in Patients With Type 2 Diabetes

Information source: Merck
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: MK0893 (Drug); Comparator: placebo (Drug); Comparator: propranolol (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

Overall contact:
Toll Free Number, Phone: 1-888-577-8839

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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety Study

Primary outcome: Time required to recover from insulin-induced hypoglycemia

Secondary outcome: Safety and tolerability of combined treatment with MK0893 and propranolol based on assessment of clinical and laboratory adverse experiences

Eligibility

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

Criteria:

Inclusion Criteria:

- Patient has Type 2 Diabetes (T2DM)

- Patient is either: Not on an oral antihyperglycemic medication for at least 6 weeks;

on a single oral antihyperglycemic medication that is not a PPARg agonist (e. g. Avandia); OR on a combination of no more than two antihyperglycemic medications that are not PPARg agonists

- Patients have not received insulin for at least 6 months

- Patient has not been treated with a PPARg agonist for at least 12 weeks

- Patient has been a nonsmoker for at least 6 months

Exclusion Criteria:

- Patient has a history of stroke, seizures, or neurological disorders

- Patient cannot tolerate insulin or propranolol

- Patient has a history of asthma, emphysema or chronic bronchitis

- Patient 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

- Patient is on or may require treatment with drugs that affect the immune system or

with corticosteroids

- Patient has a history of heart failure or coronary artery disease

- Patient has a history of uncontrolled high blood pressure

- Patient is HIV, hepatitis B or hepatitis C positive

- Patient has a history of Type 1 diabetes

Locations and Contacts

Toll Free Number, Phone: 1-888-577-8839

Call for Information, Chula Vista, California 91911, United States; Recruiting
Additional Information

Starting date: April 2009
Ending date: January 2010
Last updated: October 8, 2009

Page last updated: October 19, 2009

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