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
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